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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phenylephrine bolus

Group Type EXPERIMENTAL

Phenylephrine bolus

Intervention Type DRUG

10 ml of 100mcg/ml phenylephrine and placebo infusion

Phenylephrine infusion

Group Type EXPERIMENTAL

phenylephrine infusion

Intervention Type DRUG

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

Interventions

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Phenylephrine bolus

10 ml of 100mcg/ml phenylephrine and placebo infusion

Intervention Type DRUG

phenylephrine infusion

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No