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The Internet Journal of Anesthesiology Volume 29 Number 1 A Comparative Study Of Ondansetron And Granisetron For
Prevention Of Nausea And Vomiting Following
Laparoscopic Surgeries
A Chidambaram, K Bylappa, P Somasekaram
A Chidambaram, K Bylappa, P Somasekaram. A Comparative Study Of Ondansetron And Granisetron For Prevention OfNausea And Vomiting Following Laparoscopic Surgeries. The Internet Journal of Anesthesiology. 2010 Volume 29 Number1.
Background and objectives Laparoscopic surgeries are associated with an appreciably high rate of post operative nausea andvomiting (PONV). This study was designed to compare the effectiveness of Ondansetron with that of Granisetron for preventionof PONV after laparoscopic surgery and their effect on clinical recovery and recovery time.Methods This is a randomizedprospective study of 60 adult patients of both sexes received either Ondansetron 4mg or Granisetron 2mg intravenously at theend of surgery. Perioperative anaesthetic care was standardized in all patients. Patients were then observed 24 hours afteradministration of the study drug.Results A complete response (defined as no PONV and no need for another rescue antiemetic)was achieved in 75% of the patients given ondansetron and 86% of the patients given granisetron with (p<.05%). No significantdifference observed in the recovery time from anesthesia between the two drugs and slight differences in the adverse eventswere observed between the two groups.Conclusion This study concludes that the prophylactic intravenous administration ofGranisetron is more effective drug than ondansetron for controlling postoperative nausea and vomiting with fewer incidences ofside effects.
vomiting is considerably high3.
Despite continuing advances in anesthetic and surgical The introduction of 5-HT receptor antagonist was a major techniques, both the incidence and severity of post-operative advancement in the treatment of post operative nausea and nausea and vomiting have remained relatively unchanged.
vomiting because of less adverse effects that were observed Post operative nausea and vomiting are the most common than commonly used traditional antiemetic4.
distressing symptoms occurring after surgery1. These factorsprevent patients returning home at the end of the day, after Certain procedure such as middle ear surgeries, strabismus surgery and necessitating readmission to the hospital. The surgeries, laparoscopies, gynecological surgeries are etiology of postoperative nausea, vomiting is complex and associated with higher incidence of PONV5. Ondansetron is depends upon a variety of factors, including patient selective 5-hydroxy tryptamine receptor antagonist possess characteristic, type of surgery, anaesthetic technique and property of superior antiemetic prophylaxis6. This has been postoperative care.
now used widely for the treatment of postoperative nauseaand vomiting7,8. Granisetron is recently introduced, 5- Postoperative nausea and vomiting are more common in hydroxy tryptamine receptor antagonist, with stronger 5HT female patients1. Women undergoing Laparoscopic surgeries binding. It is more potent and longer acting antemetic agent are particularly at risk of experiencing these problems. It compared to Ondansetron against emesis associated with leads to dehydration and electrolyte imbalance. These factors chemotherapy, and have been found to be very effective for reduce the quality of life of the patients and interfering with preventing PONV after laparoscopic surgery9. Granisetron continuation of curative therapy2. So an effective antiemetic has less incidence of side effects10.
therapy is needed. In the absence of any antiemetic treatmentfollowing laparoscopic surgery the incidence of nausea and The aim of this clinical trial is to compare, the efficacy of A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
prophylactic administration of 4mg Ondansetron i.v. with was reversed with inj glycopyrollate 0.005mgkg-1 and that of 2mg Granisetron i.v. administered at the end of the neostigmine 0.05mgkg-1 and patient was extubated.
surgery in preventing PONV in patients undergoinglaparoscopic surgeries, their effect on clinical recovery and The recovery time (in minutes) was measured from the time recovery time and the side effects of Inj Ondansetron and Inj nitrous oxide was switched off until the patient respond to simple verbal commands. The patients were then assessedwith the help of a clinical recovery score, to compare effects MATERIAL AND METHODS
on clinical recovery. The score consisted of simple questions A randomized prospective study was conducted in 60 adult to evaluate vigilance, cognition and orientation (Kumar et al patients of class ASA I and ASA II, of either sex in age group of 18-50yrs, weighing 45 to 70kgs, posted for Laparoscopic surgery. The patients were randomly dividedinto two groups of 30 each: Group ‘A' – Ondansetron group Unconscious, not arousable — 0 (n = 30), Group ‘B' – Granisetron group (n = 30). Patients Unconscious, arousable by nociceptive stimuli — 1 belonging to ASA III and ASA IV, history of drug allergy, Unconscious, arousable by verbal stimuli — 2 extremes of ages, obesity, history of motion sickness, emergency surgeries, full stomach, respiratory diseases, Awake, not attentive — 4 uraemia and Diabetes Mellitus where excluded .
Awake, attentive — 5 Ethical clearance and written informed consent was taken from patients in both groups. The patients werepremedicated with 0.2mgkg -1 diazepam orally 12 hr before No understanding of simple orders — 0 giving general anaesthesia. Patients were kept NPO for 12 Good understanding of simple orders — 1 hours before surgery. In the preoperative room, iv line was secured. In the operation theatre routine monitoring devices,like pulse oximetry, NIBP, ECG monitors were attached; and baseline blood pressure, heart rate and O saturation values were recorded. Later capnography was attached after Well oriented — 2 the intubation. The anaesthetic regimen and surgical Evaluation by patient of his/her condition procedures were standardized for all patients.
Uncomfortable — 1 Anaesthesia was induced with glycopyrollate 5µgkg-1 and Comfortable — 2 intravenous thiopentone 5mgkg-1. For tracheal intubation suxamethonium 2mgkg-1 was used. Anaesthesia wasmaintained with N20 66%, O 33%, halothane 0.5-2%; Clinical Recovery Score neuromuscular blockade with intermittent doses ofvecuronium bromide and analgesia with fentanyl 1.5µgkg-1.
11 : Excellent recovery Ventilation was controlled mechanically and adjusted so as 9-10 : Good Recovery to keep the end tidal carbon dioxide 35-40 mm of Hg.
8 : Fair recovery<8 : Poor recovery Laparoscopic surgeries were performed under videoguidance. During surgery the patients were placed in The clinical recovery score was assessed at 0, 1, 2, 3 and 4 trendlenburg position wherever required and the abdomen hours after patient's arrival in recovery room and was insufflated with carbon dioxide with an intra abdominal assessments were made and appropriate recording was done.
pressure of 12-15 mm of Hg. At the end of the surgery In post anaesthesia care unit blood pressure and heart rate Group I patients received 4mg Inj ondansetron and Group II was recorded every 10 min for 30 min. Episodes of nausea patients received 2mg Inj. granisetron administered slow iv and vomiting experienced by each patient were recorded by over period of 30 seconds. At the cessation of surgery direct questioning. The number of patients who suffered patients were made supine and residual neuromuscular block

A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
nausea/vomiting was noted during the period's 0-4hrs, cases (14%) as compared to 2 cases (7%) in granisetron 4-12hrs, 12-24hrs. Rescue Antiemetic (inj. metaclopramide group in 0-4 hours(P<0.01). In 4-12 hours ondansetron 10mg) was used if patient had vomiting.
group had 3 cases(10%) of incidence of vomiting ascompared to 1 case (4%) in granisetron group(P<0.05).
Any adverse reactions of the drug like headache, dizziness, Again the incidence of vomiting was maximum during first hypersensitivity, constipation if any was noted in the 24 hr four hours and no patient in any group vomited from 12 study period. Statistical analysis was done using student‘t' hours onwards. (table: 5).
test. A ‘P' value of less then 0.05 will be considered to besignificant Need for rescue antiemetic is more in Ondansetron groupthat is 7 (23 %) compared to Granisetron group 3 (10 %).
RESULTS AND ANALYSIS
There was no significant difference in CRS and RT between Total 60 patients were included in this study. Patient the two groups as shown in (table: 6). Occurrence of side populations were comparable across the two groups with effects like headache, constipation and dizziness in respect to Age, Weight, Systolic BP, Diastolic BP, Heart Ondansetron group are 6(20%),4(13%),4(13%) respectively rate. Statistical analysis was done by using student ‘t'test compared to 4 (13%), 2(7%),2 (7 %) in Granisetron group.
and rest of the study data have been categorically analyzed.
The number of patients who suffered side effects was morein Ondansetron group. As shown in (table: 7).
In our study most of the patients in both groups belonged toage group 18-30. In both the groups females predominated males : in Ondasetron group male were 7 (23%) and females Table: 1 asa grade wise 23 (77%) and in Granisetron group male were 5 (17%) andfemales 25 (83%).
There was no significant weight difference between the twogroups: in Ondasetron group 45-60 kg - 20 (67%), 61-70kg -10 (33%); in Granisetron group 45-60 kg - 23 (77%), 61-70kg 7(23%). Mean weight ±SD of Group A was 56.93±10.62and in Group B 50.86±10.85. Both groups had almostsimilar numbers of ASAI and ASAII as shown in (table: 1).
In our study Laparoscopic tubal occlusion (LTO) Table: 3, comparision of systolic bp, diastolic bp, hr and predominated in both groups than any other surgery as shown in (table: 2). Systolic, Diastolic BP , Heart rate andoxygen saturation showed no statistically significantdifference recorded in PACU between the study groups asshown in (table:3) Occurrence of nausea in Ondanstron group and Granisetrongroup showed that incidence of nausea in 0-4 hours were 4cases (14%)in Ondansetron group as compared to 2 cases(7%) in Granisetron group(P<0.01). Incidence of nausea in4-12 hours were 2 cases (7%)in Ondansetron group ascompared to 1 cases (4%) in Granisetron group(P<0.05).
Incidence of nausea in 12-24, hours was only 1 case (4%) inOndansetron group as compared to 0 cases (0%) inGranisetron group. The incidence of nausea was greatestduring the first four hours and it was more in theOndansetron group. (Table: 4) Incidence of vomiting episodes in Ondansetron group were 4

A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
Table: 4, incidence of nausea Table: 7 , comparison of side effects Figure 5
Table:5, incidence of vomiting
DISCUSSION
Postoperative nausea and vomiting (PONV) is of
multifactorial origin. The incidence of PONV after
anaesthesia, despite the advances in antiemetic therapy in the
last decades is still found to be relatively high. The three
most common causes for admission following day care
surgery are pain, bleeding and intractable vomiting1. Factors
affecting PONV include patient related factors (age, sex,
phase of the menstrual cycle), anaesthesia related factors
(use of volatile anesthetic agents, N O, Opioid) and surgery
related factors1. Female gender has been associated with Table: 6, clinical recovery score (CRS) and recovery time higher incidence of PONV compared to male patients.1, 2 On an average, female patients suffer three times more oftenfrom PONV than men2.
Our study was aimed at comparing the antiemetic efficacy ofOndansetron and Granisetron in preventing PONV inlaparoscopic surgery. In our study the factors that wouldhave contributed to nausea and vomiting may belaparoscopic surgery, use of Halothane, use of Fentanyl etc.
Use of facemask, use of Nitrous Oxide may or may not havecontributed to nausea and vomiting. Avoidance of Pethidinetowards the end of surgery must have helped in preventingPONV3.
Laparoscopic surgery was chosen because of high incidenceof PONV associated with it. Naguib et al demonstrated thatthe incidence of PONV after laparoscopic surgeries in theirplacebo group was remarkably high (72%).11 We have conducted studies on 60 patients of ASA I and II A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
with demographic data in terms of age, weight, which were According to Gigilla20 it shows that some haemodynamic similar in the two groups. There was no significant variation in SBP, DBP and HR. Ondansetron mediated difference in Ondansetron and Granisetron (P< 0.05) in bradycardia and hypotension was reported in that study terms of Age and Weight. Study done by Pearman12 shows group. Kumar et al21 in their clinical trial on recovery score that postoperative nausea and vomiting is more common in and recovery time showed slightly lower clinical recovery young age group and obese patients.
scores with metoclopramide group compared to ondansetronwhich may be attributed to its established unpleasant Incidence of nausea in our study group was 25% in sedative pharmacological activity. They did not notice any Ondansetron group, 11% in Granisetron group. Present study significant difference in the overall incidence of drowsiness shows highly significant difference in first 0-4hr (P < 0.05).
or sedation in both the groups. They further stated that While in 4-12hrs incidence of nausea shows marginally ondansetron does not affect patients vigilance, cognition or significant difference. After 12-24hrs, there was no orientation and concluded that ondansetron (4 mg) and significant difference in nauseating episodes. Study done by metoclopramide (10 mg) do not affect the cognitive aspects Pueyo13 observed that nausea and vomiting is more common following major gynaecological surgery.
in first 6 hours post operatively. Same results are seen in thestudy done by Fujii 14.
In our study on the clinical recovery score and the recoverytime we observed slightly lower clinical recovery score in According to Raphael15, optimal dose of Ondansetron for the Ondansetron group compared to Granisetron and there preventing post operative nausea vomiting is 4 mg and half was not much of significant difference in the recovery time.
life is 3 hours. While optimal dose of Granisetron is 2 mg Incidence of side effects was significant in our study groups.
and half life is 8-9 hours. So it is observed that after 6 hours Incidence of headache was 20% in Ondansetron group while Granisetron is more effective than Ondansetron for it was 12% in Granisetron group shows statistically preventing PONV. Vomiting in the present study group was significant difference (P < 0.05).
24% in Ondansetron and 11% in the Granisetron group. Inour study group incidence of vomiting was highly significant According to study by Mitra 22, incidence of headache and in first 4hrs (P<0.01). Present study showed that Granisetron constipation is more in Ondansetron group as compared to is better than Ondansetron for preventing PONV.
Granisetron group which matches with our results. Incidence Bhattacharya16 in his study observed same results.
of constipation and dizziness also shows significantdifference in Ondansetron and Granisetron groups (P <0.05).
During 0-4hr and 4-12hrs postoperatively results aresignificant in nature (P< 0.05). After 12hrs, result of The use of rescue antiemetic in ondansetron group which vomiting was insignificant (P>0.05). Janknegt studied that if was about 7(23%) whereas in Granisetron group about Ondansetron is given at the induction time, it is ineffective 3(10%) of the patients received rescue antiemetic. Stewart23 in preventing PONV17, so we administered study drug half in his study also has same result. Updated guidelines for an hour before end of the surgery. This makes the drugs to managing postoperative nausea and vomiting were recently be effective postoperatively for longer time. Sinha18 announced at the 2006 Annual Meeting of American Society concluded the same results in his study.
of Anaesthesiologists in Chicago, Illinois, USA. Evaluatingthe current medical literature, they recommended the use of Our study shows no statistically significant difference in the antiemetics, with an emphasis on the use of the 5HT3 baseline values of haemodynamic variables between the two groups before, during or after giving study drug. Study drugsOndansertron and Granisetron was given approximately half The guidelines also suggest a potential benefit of an hour before the end of the surgery. In PACU we have combination prophylaxis. Overall the panel recommended, recorded the SBP, DBP and HR over a period of 30min at "prophylactic therapy with combination, three or more regular interval. According to our study there was no interventions, in patients at high risk for PONV.24 So we haemodynamic alteration between these results. Study have studied the effect of Granisetron 2mg i.v. versus conducted by Dev19 also shows the same results. There is no Ondansetron 4mg i.v, administered to the patients, who had haemodynamic alteration seen in PR, SBP and DBP during undergone laparoscopic surgery under general anaesthesia.
study period.
A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
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A Comparative Study Of Ondansetron And Granisetron For Prevention Of Nausea And Vomiting
Author Information
Ananth Chidambaram, MBBS., MD
Department of Anaesthesiology, Chennai Medical College Hospital and Research Center
Kiran Bylappa, MBBS., MS
Department of Otorhinolaryngology, Sapthagiri Institute of Medical Sciences & Research Center
P. Somasekaram, MBBS., MD
Professor and HOD, Department of Anaesthesiology, Sri Devaraj Urs Medical College

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