CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone 8mgfrom 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/NCT01734161
NCT01734161Phase 4Completed

A Prospective, Randomized, Double-Blinded Study to Evaluate the Efficacy of Intravenous Dexamethasone for Nausea Prophylaxis Prior to Duramorph and Bupivacaine Spinal Anesthesia for Scheduled Cesarean Section

Weill Medical College of Cornell University·interventional·Posted Nov 27, 2012·Updated Oct 15, 2019

In Brief

A Phase 4 clinical trial evaluating Dexamethasone and Placebo for Postoperative Nausea and Vomiting. Completed, enrolled 122 participants across 1 site.

Detailed Summary

Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Study Details

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

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 27, 2012
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.6 years ago

Interventions

Dexamethasonedrug

8mg IV dexamethesone given

Placebodrug

Subjects randomized to placebo receive 50cc normal saline