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

NCT00796328 | Terminated Phase 4 Results DMC

• 1 other identifier: IWK-4462-2008
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension

  The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.

  Spinal administration until delivery

Study Arms (1)

1

EXPERIMENTAL

Drug: Phenylephrine infusion

Interventions

Phenylephrine infusion DRUG

Up-down, biased coin design

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
• American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
• Age ≥ 18 years (Standard within the obstetrical literature)
• Term gestational age
• English-speaking

You may not qualify if:

• Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intra-arterial catheter due to limitations in size)
• Height \< 5'0" (Women \< 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
• Laboring women
• Urgent or emergency cesarean delivery
• Hypertensive disease of pregnancy
• Severe maternal cardiac disease
• Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
• Fetal anomalies or intrauterine fetal death
• Failed spinal anesthesia
• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Results Point of Contact

• Title: Dr. Ron George
• Organization: IWK Health Centre

rbgeorge@dal.ca

470-6627

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 23, 2018
• Results First Posted: April 21, 2014

Record last verified: 2018-03