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Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

NCT01481740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-04-23

Study results available
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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.

Conditions

Interventions

DRUG

Phenylephrine bolus

10 ml of 100mcg/ml phenylephrine and placebo infusion

DRUG

phenylephrine infusion

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

Sponsors & Collaborators

Principal Investigators

  • Ronald B George, MD FRCPC · IWK Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481740 on ClinicalTrials.gov