CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02541019
NCT02541019Phase 4Completed

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

Hospital Federal de Bonsucesso·interventional·Posted Sep 4, 2015·Updated Aug 9, 2017

In Brief

A Phase 4 clinical trial evaluating Ondansetron and Palonosetron for Postoperative Nausea and Vomiting. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Despite the development of new drugs, nausea and vomiting after surgery (PONV) are still frequent. Antagonists 5HT3 receptors, such as ondansetron and palanosetron, are among the main characterized prophylactic agents in patients at high risk, however there are few studies comparing the efficacy of these drugs and no study that addresses women aged over 60 years. In this prospective, randomized, double-blind study, 80 women nonsmokers, undergoing laparoscopic cholecystectomy will be divided into two groups, receiving during anesthetic induction intravenous ondansetron 4 mg (n = 40) or palonosetron 75 mcg (n = 40) prophylaxis of PONV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 4, 2015
Enrollment StartOct 1, 2015
Primary CompletionJan 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.8 years ago

Interventions

Ondansetrondrug

4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.

Palonosetrondrug

75 mcg IV, one minute before the anesthesia induction.