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

IWK Health Centre

Status and phase

Completed

Phase 4

Conditions

Hypotension

Treatments

Drug: phenylephrine infusion

Drug: Phenylephrine bolus

Study type

Interventional

Funder types

Other

Identifiers

NCT01481740

4999-01460

Details and patient eligibility

About

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.

Enrollment

178 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

English speaking
ASA Physical Status I-II
Non-laboring women
Single gestations ≥ 36 weeks
Obese women (Body Mass Index 35 - 55 kg/m2)
Non-emergent CD under spinal anesthesia

Exclusion criteria

Height < 5'0"
Antiemetic drug use in the 24 hours prior to CD
Allergy to phenylephrine, or any other standardized medication
Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)
Chronic hypertension receiving antihypertensive treatment
Severe Cardiac disease in pregnancy with marked functional limitations
Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Subject enrollment in another study involving a study medication within 30 days of CD
Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection