title: Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: a randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Palonosetron is comparable to ondansetron for PONV prophylaxis in elective laparoscopic cholecystectomy when administered as single pre-induction dose.
authors.affiliation: Department of Anesthesiology and Critical Care, Command Hospital (Eastern Command), Alipore, India.
authors.forename: Baisakhi
authors.initials: B
authors.lastname: Laha
authors.forename: Avijit
authors.initials: A
authors.lastname: Hazra
authors.forename: S
authors.initials: S
authors.lastname: Mallick
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D017081:Cholecystectomy, Laparoscopic; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000627:therapeutic use*; D000077924:Palonosetron; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy* / Q000209:etiology; D011812:Quinuclidines / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D012702:Serotonin Antagonists; D017294:Ondansetron; D000077924:Palonosetron
keywords: Laparoscopic cholecystectomy; ondansetron; palonosetron; postoperative nausea and vomiting; randomized controlled trial
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