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Randomized Controlled Trial
. 2013 Jan-Feb;45(1):24-9.
doi: 10.4103/0253-7613.106430.

Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial

Baisakhi Laha  1 , Avijit Hazra, S Mallick
Affiliations
Randomized Controlled Trial

Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial

Baisakhi Laha et al. Indian J Pharmacol. 2013 Jan-Feb.

Abstract

Objectives: Incidence of postoperative nausea and vomiting (PONV), without active intervention, following laparoscopic cholecystectomy is unacceptably high. We evaluated the effectiveness of intravenous (IV) palonosetron in counteracting PONV during the first 24 hrs following laparoscopic cholecystectomy, using ondansetron as the comparator drug.

Materials and methods: In a randomized, controlled, single blind, parallel group trial, single pre-induction IV doses of palonosetron (75 mcg) or ondansetron (4 mg) were administered to adult patients of either sex undergoing elective laparoscopic cholecystectomy. There were 49 subjects per group. The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform. The primary effectiveness measure was total number of PONV episodes in the 24 hrs period following end of surgery. The frequencies of individual nausea, retching and vomiting episodes, visual analog scale (VAS) score for nausea at 2, 6 and 24 hrs, use of rescue antiemetic (metoclopramide), number of complete responders (no PONV or use of rescue in 24 hrs) and adverse events were secondary measures.

Results: There was no statistically significant difference between the groups in primary outcome. Similarly, the frequencies of nausea, retching and vomiting episodes, when considered individually, did not show significant difference. Nausea score was comparable at all time points. With palonosetron, 14 subjects (28.6%) required rescue medication while 13 (26.5%) did so with ondansetron. The number of complete responders was 14 (28.6%) and 16 (32.7%), respectively. Adverse events were few and mild. QTc prolongation was not encountered.

Conclusion: Palonosetron is comparable to ondansetron for PONV prophylaxis in elective laparoscopic cholecystectomy when administered as single pre-induction dose.

Keywords: Laparoscopic cholecystectomy; ondansetron; palonosetron; postoperative nausea and vomiting; randomized controlled trial.

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Conflict of interest statement

Conflict of Interest: No

Figures

Figure 1
Figure 1
Mean Visual Analog Scale (VAS) score for nausea at successive time points in the two study groups. There was no statistically significant difference between groups. Note that no nausea was reported in the ondansetron arm at 24 hrs
See this image and copyright information in PMC

References

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