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Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and double blind study

Authors:
  • Goa dental college and hospital
  • Goa dental college and hospital

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Objectives: To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia. Materials and methods: A prospective, randomized, and double blind clinical study was carried out with 60 patients undergoing oral and maxillofacial surgical procedures under general anesthesia. Patients were divided into two groups of 30 individuals each. Approximately two minutes before induction of general anesthesia, each patient received either 4 mg (2 mL) ondansetron or 2 mg (2 mL) granisetron intravenously in a double blind manner. Balanced anesthetic technique was used for all patients. Patients were assessed for episodes of nausea, retching, vomiting, and the need for rescue antiemetic at intervals of 0-2, 3, 6, 12, and 24 hours after surgery. Incidence of complete response and adverse effects were assessed at 24 hours postoperatively. Data was tabulated and subjected to statistical analysis using the chi-square test, unpaired t-test, or the Mann-Whitney U-test as appropriate. A P-value less than 0.05 was considered statistically significant. Results: There was no statistically significant difference between the two groups for incidence of PONV or the need for rescue antiemetic. Both study drugs were well tolerated with minimum adverse effects; the most common adverse effect was headache. The overall incidence of complete response in the granisetron group (86.7%) was significantly higher than the ondansetron group (60.0%). Conclusion: Granisetron at an intravenous dose of 2 mg was found to be safe, well tolerated, and more effective by increasing the incidence of complete response compared to 4 mg intravenous ondansetron when used for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia. Benefits of granisetron include high receptor specificity and high potency, which make it a valuable alternative to ondansetron.
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84
erative nausea and vomiting (PONV). Postoperative vomiting
may predispose patients to increased pain, bleeding, dehy-
dration, electrolyte imbalance, and delayed wound healing1.
Thus, it is prudent to minimize or prevent vomiting in such
patients.
There are a number of drugs that are used to manage
PONV including antihistaminics, phenothiazine deriva-
tives, anticholinergics, and dopamine receptor antagonists.
However, these drugs cause unwanted side effects such as
sedation, dysphoria, extrapyramidal symptoms, dry mouth,
restlessness, and tachycardia. The recently introduced 5- hy-
droxytryptamine (5-HT) receptor antagonists are devoid of
such side effects and are highly effective in the prevention
I. Introduction
Oral and maxillofacial surgical procedures under general
anesthesia have a relatively common complication of postop-
ORIGINAL ARTICLE
Rakshit Vijay Sinai Khandeparker
Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital,
#71 Trivandrum Highway, Parvathipuram, Nagercoil, Tamil Nadu 629003, India
TEL: +91-7868096436
E-mail: rockdotcom1386@gmail.com
ORCID: http://orcid.org/0000-0003-0809-792X
This is an open-access article distributed under the terms of the Creative Commons
Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/),
which permits unrestricted non-commercial use, distribution, and reproduction in any
medium, provided the original work is properly cited.
CC
Comparison of ondansetron and granisetron for antiemetic prophylaxis
in maxillofacial surgery patients receiving general anesthesia:
a prospective, randomised, and double blind study
Kiran Savant1, Rakshit Vijay Sinai Khandeparker2, Vikas Berwal3, Purva Vijay Khandeparker4, Hunny Jain5
1Oral and Maxillofacial Surgery, Private Practitioner, Bengaluru,
2Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital, Nagercoil,
3Department of Oral and Maxillofacial Surgery, Post Graduate Institute of Medical Sciences (PGIMS), Rohtak,
4Department of Oral and Maxillofacial Surgery, Hospicio Hospital, Margao,
5Department of Oral and Maxillofacial Surgery, Yogitha Dental College, Ratnagiri, India
Abstract (J Korean Assoc Oral Maxillofac Surg 2016;42:84-89)
Objectives:
To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and
vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia.
Materials and Methods:
A prospective, randomized, and double blind clinical study was carried out with 60 patients undergoing oral and maxil-
lofacial surgical procedures under general anesthesia. Patients were divided into two groups of 30 individuals each. Approximately two minutes before
induction of general anesthesia, each patient received either 4 mg (2 mL) ondansetron or 2 mg (2 mL) granisetron intravenously in a double blind man-
ner. Balanced anesthetic technique was used for all patients. Patients were assessed for episodes of nausea, retching, vomiting, and the need for rescue
antiemetic at intervals of 0-2, 3, 6, 12, and 24 hours after surgery. Incidence of complete response and adverse effects were assessed at 24 hours postop-
eratively. Data was tabulated and subjected to statistical analysis using the chi-square test, unpaired t-test, or the Mann-Whitney U-test as appropriate.
A
P
-value less than 0.05 was considered statistically significant.
Results:
There was no statistically significant difference between the two groups for incidence of PONV or the need for rescue antiemetic. Both study
drugs were well tolerated with minimum adverse effects; the most common adverse effect was headache. The overall incidence of complete response
in the granisetron group (86.7%) was significantly higher than the ondansetron group (60.0%).
Conclusion:
Granisetron at an intravenous dose of 2 mg was found to be safe, well tolerated, and more effective by increasing the incidence of com-
plete response compared to 4 mg intravenous ondansetron when used for antiemetic prophylaxis in maxillofacial surgery patients receiving general
anesthesia. Benefits of granisetron include high receptor specificity and high potency, which make it a valuable alternative to ondansetron.
Key words:
Anesthesia, General, Granisetron, Ondansetron, Postoperative nausea and vomiting
[paper submitted 2015. 10. 24 / revised 1st 2015. 12. 16, 2nd 2016. 1. 18 / accepted 2016. 2. 2]
Copyright
2016 The Korean Association of Oral and Maxillofacial Surgeons. All
rights reserved.
http://dx.doi.org/10.5125/jkaoms.2016.42.2.84
pISSN 2234-7550·eISSN 2234-5930
Ondansetron vs granisetron for antiemetic prophylaxis in oral and maxillofacial surgery
85
ic evaluation by the anesthetist. The night before surgery, all
patients were given oral diazepam (5 mg) and ranitidine (150
mg) and kept
nil per os
(nothing by mouth) after 10:00 p.m.
followed by oral diazepam (5 mg) and ranitidine (150 mg) at
6:00 a.m. on the day of surgery as per the anesthetists order.
Upon arrival in the operation theatre, patients were connected
to the intravenous line and intravenous fluids were started;
monitors for electrocardiogram, pulse-oximeter, and non-
invasive blood pressure (NIBP) were also connected and set at
monitoring mode. Patients were premedicated with an injec-
tion of midazolam (0.05 mg/kg) and pentazocine (0.5 mg/kg).
Patients were randomly allocated to the two study drug
groups (A and B) and in a double blind manner; the anesthe-
tist administered one of the groups intravenously followed by
induction using injections of thiopentone sodium (5 mg/kg)
and glycopyrrolate (0.2 mg) two minutes later. All patients
received a suxamethonium (2 mg/kg) injection for relaxation
and then were intubated with an appropriate size endotracheal
tube with a throat pack. Patients were maintained on con-
trolled ventilation with oxygen, nitrous oxide, and halothane
0.05% to 1%, and muscle relaxation was maintained with an
injection of vecuronium (0.05 mg/kg). Routine prophylaxis
was performed with intravenous injection of amoxicillin (1
g) and intravenous dexamethasone (8 mg) was administered
to counteract swelling during the postoperative period. Once
the surgical procedure was completed, halothane and nitrous
oxide were discontinued and the patient was ventilated with
100% oxygen. The throat pack was then removed, oral suc-
tioning was completed, and an appropriate size nasogastric
tube was inserted. Patients were reversed with injections of
neostigmine (0.05 mg/kg) and glycopyrrolate. They were
extubated and a nasopharyngeal airway was established,
then patients were transferred to a post anaesthetic care unit
(PACU). In the PACU, patients were supplemented with
oxygen. Monitors including a pulse-oximeter, electrocar-
diogram, and NIBP were attached and placed in monitoring
mode. Once adequate recovery was achieved, the patients
were transferred to the department wards.
Postoperatively, all patients were assessed at the PACU
and department wards for episodes of nausea, retching, vom-
iting, and the need for rescue antiemetic at intervals of 0-2,
3, 6, 12, and 24 hours. Episodes of PONV were identified by
spontaneous complaints from patients or by direct question-
ing. The patients were observed for 24 hours postoperatively
for incidence of complete response and adverse effects.
Complete response was defined as the absence of nausea,
retching, or vomiting and no need for rescue antiemetic dur-
and treatment of PONV. The drug commonly used to treat
PONV is ondansetron (4 mg) via an intravenous route2.
The prophylactic efficacy of ondansetron in preventing
PONV has already been established in various surgical pro-
cedures requiring general anesthesia3-7. However, with regard
to oral and maxillofacial surgical procedures under general
anesthesia, some studies have shown ineffectiveness of 4 mg
ondansetron prophylaxis, whereas another study has shown
that ondansetron is more effective than metoclopramide1,8,9.
Therefore, the efficacy of ondansetron in preventing PONV
has not been clearly established in patients undergoing oral
and maxillofacial surgical procedures under general anesthe-
sia.
Granisetron is another recently introduced 5-HT receptor
antagonist which has good potency and a longer duration of
action against emesis. The optimal dose of granisetron in pre-
venting PONV is 2 mg via an intravenous route. We did not
discover any literature comparing any other highly effective
prophylactic drug with ondansetron for prevention of PONV
in maxillofacial surgical patients under general anesthesia.
Therefore, this study was undertaken to compare the effi-
cacy of intravenous ondansetron 4 mg (2 mL) and granisetron
2 mg (2 mL) in preventing PONV in patients undergoing oral
and maxillofacial surgical procedures under general anesthe-
sia.
II. Materials and Methods
This prospective and randomized clinical study was com-
pleted at Bapuji Dental College and Hospital (Davangere,
India) from October 2011 to October 2012 and was approved
by the Institutional Ethics Committee of Bapuji Dental Col-
lege and Hospital. Sixty patients of either sex were allocated
into two equal groups in a double blind and randomized man-
ner. Individuals between the ages of 18 to 70 years, weighing
more than 40 kg, having American Society of Anesthesiolo-
gists (ASA) I-II category, and those scheduled for oral and
maxillofacial surgery under general anesthesia were included
in the study. Patients were excluded if they were unable or
unwilling to give informed consent, had documented hyper-
sensitivity to any of the study drugs, had a history of motion
sickness or previous PONV, had taken antiemetic drugs
within 24 hours before surgery, had a history of neurological
or renal diseases, were medically compromised and not con-
sidered fit for surgery under general anesthesia, or had a past
history of adverse reactions to the study drugs.
One day prior to surgery, all patients received a pre-anesthet-
J Korean Assoc Oral Maxillofac Surg 2016;42:84-89
86
thologies, open reduction and internal fixation of panfacial
fractures, and bi-jaw orthognathic surgical procedures.(Table
1) The two groups were comparable with regard to the differ-
ent types of surgical procedures performed. The demographic
data of the study population is presented in Table 2. The pres-
ent study included 20 males and 10 females with a mean age
of 38.0±14.9 years in group A, and 23 males and 7 females
with a mean age of 31.8±11.1 years in group B. The mean
body weight was 59.2±13.1 kg in group A and 56.0±11.8 kg
in group B. The mean duration of surgery in groups A and
B was 121.8±84.9 minutes and 139.4±80.3 minutes, respec-
tively. The mean duration of anesthesia was 150.4±85.1 min-
utes in group A and 166.4±85.0 minutes in group B. The two
groups contained individuals with comparable demographics.
The incidence of nausea was 16.7% (n=5) in group A and
3.3% (n=1) in group B over a 24-hour period (
P
>0.05).(Table
3) One patient in both groups had an episode of retching over
a 24-hour period (
P
>0.05).(Table 3) Similarly, the results for
vomiting when compared between the two groups were not
statistically significant (
P
>0.05).(Table 4) When examining
the need for rescue medication, only a single patient in the
ondansetron group needed an injection of metoclopramide (10
mg) as compared to no patients in the granisetron group over
the 24-hour period (
P
>0.05).(Table 4) Headache was the only
ing the 24 hour observation period. Rescue antiemetic in the
form of an intravenous injection of metoclopramide (10 mg,
PERINORM; IPCA Labs, Mumbai, India) was given in the
event of one or more episodes of vomiting depending on the
observers discretion.
These postoperative assessments were recorded on a stan-
dardized form. Upon completion of the study, un-blinding
revealed that group A (n=30) received 2 mL (4 mg) ondanse-
tron (NEOMIT; Neon Laboratories Ltd., Mumbai, India) and
group B (n=30) received 2 mL (2 mg) granisetron (GRANI-
FORCE; Mankind Pharma, New Delhi, India). The data was
subjected to statistical analysis by a chi-square test, unpaired
t-test, or the Mann-Whitney U-test as appropriate (SPSS ver-
sion 13; SPSS Inc., Chicago, IL, USA). A
P
-value of less
than 0.05 was considered significant.
III. Results
All surgical procedures were performed by a single oral
and maxillofacial surgeon. The surgical procedures per-
formed in this study included oncologic resections and
reconstructions, excision and reconstruction of surgical pa-
Table 1. Classification of surgical procedures between the two
groups
Surgical procedure Group A
(n)
Group B
(n)
Oncologic resections and reconstruction
Surgical pathologies: excision and reconstruction
Open reduction and internal fixation of panfacial
trauma
Orthognathic surgeries (bijaw procedures)
Total
8
6
12
4
30
9
6
11
4
30
Group A: ondansetron group, Group B: granisetron group.
Kiran Savant et al: Comparison of ondansetron and granisetron for antiemetic
prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective,
randomised, and double blind study. J Korean Assoc Oral Maxillofac Surg 2016
Table 3. Assessment of postoperative nausea and retching
Time (hr) Nausea assessment Retching assessment
Group A Group B
P
-value1Group A Group B
P
-value2
0-2
3
6
12
24
4 (13.3)
1 (3.3)
1 (3.3)
1 (3.3)
5 (16.7)
1 (3.3)
0 (0)
1 (3.3)
1 (3.3)
1 (3.3)
0.690, NS
1.000, NS
0.850, NS
0.850, NS
0.649, NS
0 (0)
0 (0)
0 (0)
0 (0)
1 (3.3)
0 (0)
0 (0)
0 (0)
0 (0)
1 (3.3)
-
-
-
-
1.000, NS
(NS: not significant)
Group A: ondansetron group, Group B: granisetron group.
Values are presented as number (%).
1Chi-square test. 2Unpaired t-test.
Kiran Savant et al: Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and
double blind study. J Korean Assoc Oral Maxillofac Surg 2016
Table 2. Demographic data of the study population
Group A (n=30) Group B (n=30)
Age (yr)
Weight (kg)
Sex (male/female)
Duration of surgery (min)
Duration of anesthesia (min)
38.0±14.9
59.2±13.1
20/10
121.8±84.9
150.4±85.1
31.8±11.1
56.0±11.8
23/7
139.4±80.3
166.4±85.0
Group A: ondansetron group, Group B: granisetron group.
Values are presented as mean±standard deviation or number only.
Kiran Savant et al: Comparison of ondansetron and granisetron for antiemetic
prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective,
randomised, and double blind study. J Korean Assoc Oral Maxillofac Surg 2016
Ondansetron vs granisetron for antiemetic prophylaxis in oral and maxillofacial surgery
87
postoperative opioids10. Such a scenario makes prophylactic
anti-emetic treatment an attractive option.
It is well appreciated that a number of factors including
various insults, chemotherapeutic agents, radiation, etc. may
lead to the release of serotonin from the enterochromaffin of
the gastrointestinal tract. Released serotonin may then bind
to certain 5-HT receptors and promote nausea/vomiting.
The highest concentration of 5-HT receptors is found in the
solitary tract nucleus (STN) and the chemoreceptor trigger
zone (CTZ) of the central nervous system. It is believed that
5-HT receptor antagonists suppress nausea and vomiting at
these STN and CTZ sites. All 5-HT receptor antagonists have
the same basic double nitrogen ring backbone within their
chemical structure. This may be the chemical site of action
of the 5-HT receptor antagonists on serotonin, which is ni-
trogen based and contains a six and five member ring11. The
5-HT receptor antagonists prevent serotonin from activating
and sensitizing the vagal afferent nerves, which causes nau-
sea and vomiting. The 5-HT receptor antagonists ameliorate
nausea/vomiting in a number of circumstances and have been
utilized as important antiemetics for multiple conditions such
as chemotherapy-induced nausea/vomiting, radiation-induced
emesis, and PONV12.
The development of selective 5-HT receptor antagonists
has dramatically improved the treatment of nausea and
vomiting12. Ondansetron is a commonly used 5-HT receptor
antagonist to prevent patient nausea and vomiting. Its onset
of action is less than 30 minutes after an intravenous injec-
tion with a duration of 12 to 24 hours. The mean elimination
half-life is four hours in adults, while most paediatric patients
below 15 years of age have a shorter plasma half-life of 2.4
hours13. Granisetron is a recently introduced 5-HT receptor
antagonist which has good potency and a longer duration of
action against emesis. The onset of action following a single
adverse effect occurring more frequently in group A (n=3,
10.0%) as compared to group B (n=1, 3.3%); however, the
result was statistically not significant (
P
>0.05). The incidence
of complete response over a 24-hour postoperative period
was 60.0% (n=18) in group A as compared to 86.7% (n=26)
in group B, which was statistically significant (
P
=0.021,
P
<0.05).(Table 5)
IV. Discussion
In the practice of oral and maxillofacial surgery, PONV is
a common problem with approximately 21% to 63% of oral
and head and neck surgery patients reporting such symp-
toms9. When separating postoperative nausea from vomiting,
the overall incidence of nausea ranges from 22% to 41%,
while that of vomiting ranges from 12% to 33%. PONV is an
important factor contributing to patient discomfort and dissat-
isfaction regarding their office, clinic, or hospital experience.
Studies report that avoiding postoperative nausea, vomiting,
retching, and gagging on the endotracheal tube are greater
concerns among patients than postoperative pain10.
Patients undergoing oral and maxillofacial surgery under
general anesthesia are at a moderate to high risk for PONV as
most of these surgeries have a long duration with oral/nasal
oozing leading to ingestion of blood and involve the use of
Table 4. Assessment of postoperative vomiting and need for rescue medication
Time (hr) Vomiting Need for rescue medication
Group A Group B
P
-value1Group A Group B
P
-value2
0-2
3
6
12
24
1 (3.3)
1 (3.3)
1 (3.3)
1 (3.3)
2 (6.7)
0 (0)
1 (3.3)
0 (0)
0 (0)
0 (0)
0.321, NS
1.000, NS
0.321, NS
0.321, NS
0.155, NS
0 (0)
0 (0)
0 (0)
0 (0)
1 (3.3)
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
-
-
-
-
1.000, NS
(NS: not significant)
Group A: ondansetron group, Group B: granisetron group.
Values are presented as number (%).
1Chi-square test. 2Unpaired t-test.
Kiran Savant et al: Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and
double blind study. J Korean Assoc Oral Maxillofac Surg 2016
Table 5. Incidence of complete response
Group A (n=30) Group B (n=30)
P
-value1
No. of patients
Overall percentage
18
60.0
26
86.7 0.021*
Group A: ondansetron group, Group B: granisetron group.
1Mann-Whitney U-test.
*Statistically significant,
P
<0.05.
Kiran Savant et al: Comparison of ondansetron and granisetron for antiemetic
prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective,
randomised, and double blind study. J Korean Assoc Oral Maxillofac Surg 2016
J Korean Assoc Oral Maxillofac Surg 2016;42:84-89
88
nous administration just before induction provides a suffi-
cient postoperative antiemetic effect.
Postoperative assessment of nausea, retching, and vomiting
at 0-2, 3, 6, 12, and 24-hour intervals in both ondansetron and
granisetron groups was found to be statistically insignificant
(
P
>0.05). This finding is comparable to the study by Bestas
et al.22, who compared the effects of ondansetron and granis-
etron on PONV in adult patients undergoing laparoscopic
cholecystectomy and observed no significant differences in
PONV between the active treatment groups.
In our study, patients in both the ondansetron and granis-
etron groups did not receive rescue antiemetic during the
0-2, 3, 6, and 12-hour intervals. At the 24-hour interval, one
patient out of 30 (3.3%) in the ondansetron group received
rescue antiemetic in the form of intravenous metoclopramide
(10 mg), while no patients in the granisetron group received
rescue antiemetic. These results were not statistically signifi-
cant and comparable to studies reported in the literature2,22,23.
Both drugs were relatively well-tolerated and had mini-
mal adverse effects. In the ondansetron group, three patients
(10.0%) complained of headache whereas as one patient
(3.3%) reported similar in the granisetron group. These re-
sults were comparable to studies by Figueredo and Canosa21
that showed a 7.05% incidence of headache with ondansetron
and studies by Fujii et al.16 that showed a 2% to 5% incidence
of headache with granisetron. Dizziness, rashes, allergic reac-
tions, and other adverse effects were not reported in the entire
study population.
In our study, complete response occurred in 60% of the
cases in the ondansetron group, which is comparable to the
studies conducted by Naguib et al.23 (65.5%) and Kovac et
al.11 (64%). The complete response in the granisetron group
occurred in 86.7% cases, which is comparable to the work
done by Mikawa et al.19 (83%) and Fujii et al.16,18,20 (85%).
This result was statistically significant (
P
=0.021;
P
<0.05) and
similar to the study by Bhattacharya and Banerjee2. However,
the incidence of complete response in our study (complete
response=60.0% in ondansetron group and 86.7% in granis-
etron group) was less than previously reported by Bhattacha-
rya and Banerjee2 (complete response=80% in ondansetron
group and 93% in granisetron group). This may be explained
by a difference in the type and duration of surgical proce-
dures included in the present study, as tubal ligations were
also included in their study.
intravenous dose of granisetron is within 30 minutes and with
a duration of more than 24 hours. Its elimination half-life is
8.95 hours14. Granisetron is a highly selective 5-HT recep-
tor antagonist that has little or no affinity for other receptors,
a characteristic that is thought to underlie its favorable side
effects and safety profile. Extensive clinical trial data have
shown granisetron to be an effective and well-tolerated agent
for the treatment of nausea and vomiting in oncology and sur-
gical settings15. The higher control rate with granisetron may
be due to its higher specificity and affinity for 5-HT receptors
and its longer serum half-life compared to other agents15.
The etiology of PONV is complex and dependent on a
variety of factors, including age, obesity, a history of mo-
tion sickness and/or previous PONV, menstruation, surgical
procedure, anesthetic technique, and postoperative pain16. In
our study, the treatment groups were comparable with respect
to patient demographics, surgical procedures performed, an-
esthetics administered (balanced anesthesia), and analgesics
used postoperatively. Patients with a history of motion sick-
ness and/or previous PONV, and those who were menstruat-
ing were excluded because of a relatively high risk of PONV.
Therefore, the difference in a complete response (no PONV,
no rescue medication) between the groups can be attributed
to the study drug.
One drawback of our study design was the lack of a control
group receiving a placebo. Studies have shown that ondan-
setron and granisetron are better antiemetics for preventing
PONV compared to a placebo4,6,7,17-20. Aspinall and Goodman
have suggested that placebo controlled trials may be unethi-
cal if active drugs are available, because PONV are common
and distressing symptoms against which there is effective
treatment16. Therefore, a control group was not included in
our study.
The recommended dose of ondansetron for PONV prophy-
laxis is 4 mg5,6,17,21. In our study, we selected an intravenous
dosage of 4 mg ondansetron based on previous studies by
McKenzie et al.4, Honkavaara5, Kovac et al.17, and prophy-
lactic ondansetron-meta analysis by Figueredo and Canosa21.
Granisetron (40 μg/kg) is considered an appropriate dosage
for preventing postoperative emesis after anesthesia16. The in-
travenous 2 mg dosage of granisetron was based on the study
by Bhattacharya and Banerjee2.
In our study, the drugs were administered two minutes be-
fore the induction of anesthesia based on previous studies by
Honkavaara5 and Bhattacharya and Banerjee2. Ondansetron
and granisetron reached a peak plasma concentration within
30 minutes of intravenous administration22. Hence intrave-
Ondansetron vs granisetron for antiemetic prophylaxis in oral and maxillofacial surgery
89
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1996;76:316-8.
6. Dershwitz M, Conant JA, Chang Y, Rosow CE, Connors PM. A
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7. Liberman MA, Howe S, Lane M. Ondansetron versus placebo for
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D, Baughman VL, et al. Efficacy of repeat intravenous dosing of
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18. Fujii Y, Tanaka H, Toyooka H. Optimal anti-emetic dose of granis-
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19. Mikawa K, Takao Y, Nishina K, Maekawa N, Obara H. The anti-
emetic efficacy of prophylactic granisetron in gynecologic surgery.
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23. Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal
M, el Gammal K, et al. Prophylactic antiemetic therapy with on-
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V. Conclusion
In conclusion, granisetron at an intravenous dose of 2 mg
was found to be safe, well tolerated, and more effective than
a 4 mg intravenous ondansetron for antiemetic prophylaxis in
maxillofacial surgery patients receiving general anesthesia,
and can be employed as routine antiemetic prophylaxis for
PONV. The benefits of granisetron, including high receptor
specificity and high potency, make it a valuable alternative to
ondansetron. The present study has not addressed the issues
of economy and surrogate variables such as hospital dis-
charge times, expenses incurred towards treating established
PONV, or sequelae of PONV, which can be considered
shortcomings of this study. Nevertheless, a study addressing
these issues should be carried out in the near future.
Conflict of Interest
No potential conflict of interest relevant to this article was
reported.
ORCID
Kiran Savant,
http://orcid.org/0000-0003-0867-5523
Rakshit Vijay Sinai Khandeparker,
http://orcid.org/0000-
0003-0809-792X
Vikas Berwal,
http://orcid.org/0000-0002-7121-1986
Purva Vijay Khandeparker,
http://orcid.org/0000-0001-
7789-3773
Hunny Jain,
http://orcid.org/0000-0002-4206-3902
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... Granisetron has been found to have a prophylactic antiemetic effect on PONV in patients undergoing surgery under general anaesthesia. [10] There were some researches that have compared 5-HT3 receptor antagonist, but none of them had given convincing evidence on clinically significant differences, particularly in relation to delayed emesis. [10] Hence, the present study was intended to compare the preventive and therapeutic effects of granisetron and ondansetron on the incidence of PONV in patients undergoing elective lower segment caesarean section (LSCS) under spinal anaesthesia. ...
... [10] There were some researches that have compared 5-HT3 receptor antagonist, but none of them had given convincing evidence on clinically significant differences, particularly in relation to delayed emesis. [10] Hence, the present study was intended to compare the preventive and therapeutic effects of granisetron and ondansetron on the incidence of PONV in patients undergoing elective lower segment caesarean section (LSCS) under spinal anaesthesia. ...
... Single agent anti-emetics were used in 79% of patients, with 21% of patients receiving dual anti-emetics. Granisetron is the preferred anti-emetic of choice as it is advantageous over ondansetron due to its longer duration of action requiring it to be dosed only once a day versus three times a day in the case of ondansetron [26]. Granisetron was used in 69.7% of patients which was just below the satisfactory level. ...
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Introduction The ERAS protocol is a set of international guidelines established to expedite patients’ discharge after colorectal surgery. It does this by aiming to prevent postoperative complications early, and return the patient to normal function allowing earlier discharge. Complications such as PONV, DVT, ileus and pain are common after surgery to name a few, and delay discharge. Early treatment and prevention of these complications however is suggested to aid a patients’ return to home at earlier rates than traditional practice. Methods A prospective chart review and questionnaire was performed on patients undergoing colorectal surgery in UHL in a 6-month period from February to September 2023. Patients were approached on the 3rd day postoperatively and informed about the project. Exclusion criteria included patients who went to HDU or ICU postoperatively. Results In total, 33 patients were recruited. A target of greater than 70% compliance was reached for a variety of the elements of the ERAS protocol such as laparoscopic surgery, preoperative assessments, nutritional drinks, LMWH, oral intake within 24 h of surgery, and intraoperative antiemetics. Unsatisfactory compliance was found with documentation of postoperative antibiotics use of preoperative gabapentin. Conclusion UHL has a satisfactory compliance of over 70% with a large variety of elements of the ERAS protocol. Areas of improvement required include postoperative antibiotic and preoperative gabapentin usage. With the collective effort of the multidisciplinary team, along with education, the ERAS protocol can successfully be applied and implemented in a model 4 hospital in Ireland.
... In their study, combining Gabapentin and Ramosetron did not increase the incidence of adverse events, such as dizziness, drowsiness and headache. In the same line, Savant et al. [25] reported that, in the Ondansetron group, three patients (10.0%) complained of headache whereas one patient (3.3%) reported similar in the Granisetron group. ...
... The results of this study showed that the incidence of nausea and vomiting in the granisetron group was significantly lower than ondansetron. Patients receiving granisetron showed a higher rate of a headache compared to the ondansetron group (25). In contrast, in our study the incidence of headache after drug injection was not significantly different from that of metoclopramide. ...
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... Patients undergoing laparoscopic surgery by applying abdominal gas insufflation are at higher risk of gastric contents aspiration. [14][15][16] However, none of the studies reported effect of IV medicines on preoperative gastric contents. ...
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Chapter
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Thesis
Ungefähr 30% aller chirurgischen Patienten, bei Hochrisikopatienten sogar bis zu 80%, erleiden ohne eine Prophylaxe postoperative Übelkeit und postoperatives Erbrechen (PONV). Selbst mit einer wirksamen multimodalen Prophylaxe und der Verabreichung der neuesten Wirkstoffe, liegt der Anteil in Hochrisikopatienten mit 3 bis 4 Risikofaktoren weiterhin bei bis zu 30%. Für Amisulprid (APD421), einem Dopaminantagonisten, konnte in vorherigen Studien bei einer einmaligen Dosis von 5 mg bereits ein Nutzen in der Monoprophylaxe, mit einer relativen Risikoreduktion von 20-40%, festgestellt werden. Die im vorgestellte Phase IIIb Studie wurde initiiert, um die Wirksamkeit sowie das Nebenwirkungsprofil von APD421 als Kombinationsprophylaxe mit anderen bereits etablierten Antiemetika zu überprüfen. Nachdem die Studie DP10017 genehmigt wurde, konnten Patienten eingeschlossen werden, die sich einem chirurgischen Eingriff unterzogen, der eine Allgemeinanästhesie mit volatilen Anästhetika von mindestens 1 Stunde notwendig machte. Zusätzlich mussten mindestens drei Risikofaktoren für PONV und ein schriftlich dokumentiertes Einverständnis vorliegen. Die Zuordnung fand randomisiert und verborgen statt. Nach der Narkoseeinleitung bekam der Studienteilnehmer 5 mg Amisulprid oder das Placebos, sowie ein weiteres Standard-Antiemetikum über eine Minute hinweg intravenös verabreicht. Die Anwendung der Prüfmedikation erfolgte doppelt-verblindet. Von Februar bis September 2015 konnten in 29 Zentren in Deutschland, Frankreich und den USA 1297 Patienten in die Studie eingeschlossen werden, wovon 1204 randomisiert werden und 1147 für den primären Endpunkt analysiert werden konnten. Insgesamt zeigte Amisulprid während des gesamtes Studienzeitraums eine Überlegenheit gegenüber dem Placebo, ohne dass es signifikante Nebenwirkungen bot. Somit konnte der Nutzen von Amisulprid zur PONV-Prophylaxe in Kombination mit einem weiteren Standardantiemetikum bestätigt werden
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Background: Risks involved in general anaesthesia has made spinal anaesthesia the standard anaesthetic technique for caesarean section. Spinal anaesthesia has its own side effects that may affect the mother and the unborn child's wellbeing. Ondansetron is a 5-HTreceptors antagonist, basically used as an antiemetic drug and is thought to counteract bradycardia and hypotension induced by spinal block. The primary aim of the study was to assess systolic blood pressure (SBP), diastolic blood pressure (DBP), and the mean arterial pressure (MAP) among different ondansetron doses and a control group in different time intervals. Methods:Aprospective, double-blinded, placebo- controlled, randomized clinical trial was conducted during a period of 6 months on a total of 90 patients, scheduled to undergo elective caesarean delivery under spinal anesthesia, in SMGS Hospital, Jammu. All patients with ASAI and II parturient, who were included in the study. Results: Number of patients with hypotension, was not signicantly different between the study groups. Total number of hypotensive episodes showed signicant difference and was lower in Group 2. (p=0.044) Patients of group 1 had increased frequency of administration of mephtermine in response to fall in blood pressure.In Ondansetron group, there was a dose dependant decrease in ephedrine requirement. Conclusion: Administering ondansetron (6 mg) 20 minutes before spinal block can raise the hope of increasing the efcacy of Spinal anesthesia. It may not cause reduction in the incidence of hypotension in caesarean section under spinal block, but can signicantly decrease the consumption of adrenergic agonists.
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Background: Postoperative nausea and vomiting (PONV) are common and potentially distressing adverse events (AEs) associated with surgery and anesthesia. In patients undergoing laparoscopic cholecystectomy (LC) without antiemetic prophylaxis, the incidence of PONV can be as high as 72%. Objective: The aim of this study was to investigate the prophylactic antiemetic effects of ondansetron and granisetron in patients undergoing LC when these agents are administered before the end of surgery. Methods: Patients classified by the American Society of Anesthesiologist's physical status as I or II who were scheduled for elective LC were included in this randomized, double-blind, placebo-controlled study. Anesthesia was induced with thiopental 5 mg/kg and fentanyl 2 μg/kg, and was maintained with isoflurane 1% to 3% in 50% oxygen and 50% nitrous oxide and fentanyl as needed. Approximately 20 to 30 minutes before the end of the surgery, the patients randomly received either IV ondansetron 100 μg/kg (group O), IV granisetron 40 μg/kg (group G), or normal saline (group P). Plasma levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined preoperatively and 24 hours postoperatively. The patients were observed for 24 hours for PONV and other possible AEs. Postoperative pain intensity was determined using a 10-cm visual analogue scale. Four-point satisfaction scores were determined at 24 hours. Results: Ninety patients (69 women, 21 men) participated in the study. Demographic characteristics and operative data (duration of surgery and anesthesia and amount of intraoperative fentanyl) were similar in the 3 groups. The only AE reported by patients during the 24-hour observation period was nonsevere headache. The number of patients experiencing headache was similar in group P, group O, and group G (10 [33%] patients, 6 [20%], and 10 [33%], respectively). No significant changes were found in presurgical and postsurgical plasma levels of ALT and AST in any group. The mean (SD) satisfaction scores in group O and group G (3.0 [0.4] and 3.0 [0.6], respectively) were significantly higher than those in group P (2.5 [0.5]; both, P < 0.01). Immediately after surgery (period 0), significantly more patients in the placebo group (21 [70%]) experienced PONV compared with those in the ondansetron group (9 [30%]; P < 0.05) and the granisetron group (7 [23%]; P < 0.01). During the 24-hour observation period, a significantly greater number of patients in group P (18 [60%]) required a single dose of a rescue antiemetic drug compared with those in groups O and G (9 [30%] and 6 [20%], respectively; both, P < 0.01). Conclusions: Patients administered ondansetron 100 μg/kg or granisetron 40 μg/kg 20 to 30 minutes before the end of LC had significantly higher PONV control during the 24-hour postoperative observation period than patients receiving placebo. However, there were no significant differences between the active treatment groups in the incidence of PONV, patient satisfaction, or AEs.
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The aim of the study was to compare the antiemetic effects of intravenous ondansetron 4mg (2 ml) and granisetron 2 mg(2 ml) in a double blind placebo controlled manner for prevention of nausea and vomiting in early postoperative period in patients undergoing daycare laparoscopic tubal ligation. Ninety patients (ASA I and II) undergoing laparoscopic tubal ligation under general anaesthesia were randomly allocated into three equal groups. Group A (n=30) received 4 mg (2 ml) ondansetron intravenously, group B (n=30) received 2 mg (2 ml) granisetron intravenously and group C (n=30) received 2 ml of normal saline by the same route 2 minutes before induction of general anaesthesia. Anaesthetic procedure was common to all patients. Emetic episodes in early postoperative period (first six hours) were recorded and compared in different study groups. Results were analysed by chi square test. P < 0.05 was considered to be significant. Emetic episodes were observed in 7% patients who had received intravenous granisetron (group B), in 20% who had received ondansetron (group A) and in 50% in patients who had received placebo (group C).
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It is well appreciated that a number of things (e.g., various insults, chemotherapeutic agents, radiation) may lead to the release of serotonin from the enterochromaffin of the gastrointestinal tract. Released serotonin may then bind to certain 5-HT3 receptors and promote nausea/vomiting. 5-HT3 receptor antagonists may ameliorate nausea/vomiting in a number of circumstances and have been utilized as important antiemetics for multiple conditions such as chemotherapy-induced nausea/vomiting (CINV), radiation-induced emesis (RIS), and postoperative nausea/vomiting (PONV).
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The purpose of this study was to compare the efficacy of ondansetron and metoclopramide, administered for the prophylaxis of vomiting in patients undergoing oral and maxillofacial surgery under general anesthesia. One hundred patients undergoing mandibular osteotomy surgery were studied. Patients were allocated randomly to receive 1 of 2 treatment regimens: 0.15 mg/kg ondansetron or 0.5 mg/kg metoclopramide intravenously 30 minutes before extubation. All were adults and were treated by one surgeon and all operations were the same and lasted 2.5 to 3.0 hours. The patients were assessed at 3 time periods: 0 to 3 hours, 3 to 12 hours, and 12 to 24 hours postoperatively for emesis. The data from this study showed that during the first 24-hour postoperative period, patients receiving ondansetron following general anesthesia had an 11% (11 patients) incidence of emesis compared with 28% (22 patients) in the group that received metoclopramide. In this study, ondansetron (0.1 mg/kg) was twice as effective in preventing postoperative vomiting compared with metoclopramide.
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The effect of ondansetron, a 5-HT3 antagonist, in preventing postoperative nausea and vomiting was investigated in a randomized, double-blind, placebo-controlled study of 84 patients undergoing gynecologic operation and receiving the same general anesthetic. The patients received premedication with either 16 mg oral ondansetron, or a matching placebo. The same medication was given postoperatively 8 h after the first dose. During the first hour after recovery from anesthesia, the frequencies of nausea and vomiting were 52% and 40%, respectively, in patients given placebos. In the ondansetron group nausea and vomiting developed in 17% and 12%, respectively, values significantly different from those with placebos (P less than 0.005). Similar differences were observed throughout the entire 24-h period after recovery, the incidence of nausea and vomiting being 67% and 60%, respectively, in the placebo group and 29% and 26% in the ondansetron treatment group. Ondansetron appears to be a promising antiemetic for the prevention of postoperative nausea and vomiting.