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

Hypotension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypotension

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Phenylephrine bolus10 ml of 100mcg/ml phenylephrine and placebo infusion

Drug:phenylephrine infusion60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Phenylephrine bolus

Phenylephrine infusion

Study Status

Completed

Start Date: November 2010

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Incidence of Nausea and Vomiting

Secondary Outcome: Incidence of Hypotension

Study sponsors, principal investigator, and references

Principal Investigator: Ronald B George, MD FRCPC

Lead Sponsor: IWK Health Centre

Collaborator: Duke University

More information:https://clinicaltrials.gov/show/NCT01481740

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