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Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

NCT00796328 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-04-23

Study results available
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Summary

This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min.

The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.

Conditions

  • Spinal Induced Hypotension in Cesarean Delivery

Interventions

DRUG

Phenylephrine infusion

Up-down, biased coin design

Sponsors & Collaborators

  • IWK Health Centre

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-02-28
Completion
2009-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00796328 on ClinicalTrials.gov