CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 118 enrolled
Drug / intervention
Palonosetron only +1 moredrug
Likely dose
Palonosetron with Dexamethasone 075 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/NCT00952133
NCT00952133Phase 4Completed
CompareCT.gov

Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk

NYU Langone Health·interventional·Posted Aug 4, 2009·Updated Apr 17, 2015

In Brief

A Phase 4 clinical trial evaluating Palonosetron only and Palonosetron with Dexamethasone for PONV. Completed, enrolled 118 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if subjects who receive Palonosetron plus Dexamethasone have less post-operative nausea and vomiting (PONV) than those who receive Palonosetron alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPONV
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2009
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.9 years ago

Interventions

Palonosetron onlydrug

The placebo arm will be given a dose of IV palonosetron only, and saline solution prior to surgery to see how this compares with the other combination.

Palonosetron with Dexamethasonedrug

Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.