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?
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
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.
Start Date: November 2010
Completed Date: December 2014
Phase: Phase 4
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