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

Primary Purpose

Hypotension

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Phenylephrine bolus

phenylephrine infusion

About this trial

This is an interventional treatment trial for Hypotension focused on measuring spinal induced hypotension, nausea and vomiting, cesarean delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Duke University Medical Center
IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phenylephrine bolus

Phenylephrine infusion

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Nausea and Vomiting

Secondary Outcome Measures

Incidence of Hypotension

Neonatal Acidosis

Full Information

NCT ID

NCT01481740

First Posted

July 22, 2011

Last Updated

March 22, 2018

Sponsor

IWK Health Centre

Collaborators

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT01481740

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IWK Health Centre

Collaborators

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension

Keywords

spinal induced hypotension, nausea and vomiting, cesarean delivery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phenylephrine bolus

Arm Type

Experimental

Arm Title

Phenylephrine infusion

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Phenylephrine bolus

Intervention Description

10 ml of 100mcg/ml phenylephrine and placebo infusion

Intervention Type

Drug

Intervention Name(s)

phenylephrine infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Nausea and Vomiting

Time Frame

intraoperative 2-3 hours

Title

Incidence of Nausea and Vomiting

Time Frame

2 hrs postoperative

Title

Incidence of Nausea and Vomiting

Time Frame

24hrs postoperative

Secondary Outcome Measure Information:

Title

Incidence of Hypotension

Time Frame

intraoperative - predelivery

Title

Incidence of Hypotension

Time Frame

intraoperative - postdelivery

Title

Neonatal Acidosis

Time Frame

intraoperative

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald B George, MD FRCPC

Organizational Affiliation

IWK Health Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 6K8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

29209926

Citation

George RB, McKeen DM, Dominguez JE, Allen TK, Doyle PA, Habib AS. A randomized trial of phenylephrine infusion versus bolus dosing for nausea and vomiting during Cesarean delivery in obese women. Can J Anaesth. 2018 Mar;65(3):254-262. doi: 10.1007/s12630-017-1034-6. Epub 2017 Dec 5.

Results Reference

derived

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

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