CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 178 enrolled
Drug / intervention
Phenylephrine bolus +1 moredrug
Likely dose
Phenylephrine bolus 10 mlfrom 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/NCT01481740
NCT01481740Phase 4Completed

A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients

IWK Health Centre·interventional·Posted Nov 30, 2011·Updated Apr 23, 2018

In Brief

A Phase 4 clinical trial evaluating Phenylephrine bolus and phenylephrine infusion for Hypotension. Completed, enrolled 178 participants across 2 sites in 2 countries.

Detailed Summary

Previous research regarding the use of phenylephrine has excluded obese subjects (BMI \>35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypotension
CountriesCanada, United States
CollaboratorsDuke University

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2011
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.6 years ago

Interventions

Phenylephrine bolusdrug

10 ml of 100mcg/ml phenylephrine and placebo infusion

phenylephrine infusiondrug

60ml infusion of 100mcg/ml phenylephrine and placebo bolus