CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Aprepitant +3 moredrug
Likely dose
Aprepitant 40 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/NCT01474915
NCT01474915Phase 4Completed

Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

Sergio Bergese·interventional·Posted Nov 18, 2011·Updated Dec 3, 2013

In Brief

A Phase 4 clinical trial evaluating Aprepitant, Ondansetron, and 2 other interventions for Postoperative Nausea and Vomiting (PONV) and Nausea. Completed, enrolled 122 participants across 1 site.

Detailed Summary

This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 18, 2011
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2012
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.6 years ago

Interventions

Aprepitantdrug

Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction

Ondansetrondrug

Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction

Promethazinedrug

Subject will receive 25 mg of Promethazine IV around anesthesia induction

Dexamethasonedrug

Subject will receive 10 mg of Dexamethasone IV around anesthesia induction