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

Hypotension Clinical Trial

Official title:

A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481740
• Other study ID #: 4999-01460
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2011
• Last updated: March 22, 2018
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2018
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Phenylephrine bolus
10 ml of 100mcg/ml phenylephrine and placebo infusion
• phenylephrine infusion
60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	Duke University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nausea and Vomiting		intraoperative 2-3 hours
Primary	Incidence of Nausea and Vomiting		2 hrs postoperative
Primary	Incidence of Nausea and Vomiting		24hrs postoperative
Secondary	Incidence of Hypotension		intraoperative - predelivery
Secondary	Incidence of Hypotension		intraoperative - postdelivery
Secondary	Neonatal Acidosis		intraoperative