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

This study has been terminated.

(Results Invalid, study closed, analysis cannot proceed.)

Sponsor:

Information provided by (Responsible Party):

Ronald George, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT00796328

First received: November 19, 2008

Last updated: September 3, 2014

Last verified: September 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	November 19, 2008
Last Updated Date	September 3, 2014
Start Date ^ICMJE	November 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 9, 2013)	Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension [ Time Frame: Spinal administration until delivery ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: November 21, 2008)	The ED90 of phenylephrine infused intravenously from the time the spinal is administered until delivery to prevent the subjects systolic blood pressure from decreasing by 20% or below an absolute value (90 mmHg) [ Time Frame: Spinal administration until delivery ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00796328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery
Official Title ^ICMJE	Up-down Determination of the ED90 of the Initial Rate of Infusion of Phenylephrine for the Prophylaxis of Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Spinal Induced Hypotension in Cesarean Delivery
Intervention ^ICMJE	Drug: Phenylephrine infusion Up-down, biased coin design
Study Arm (s)	Experimental: 1 Intervention: Drug: Phenylephrine infusion
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	45
Completion Date	July 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00796328
Other Study ID Numbers ^ICMJE	IWK-4462-2008
Has Data Monitoring Committee	Yes
Responsible Party	Ronald George, IWK Health Centre
Study Sponsor ^ICMJE	IWK Health Centre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	IWK Health Centre
Verification Date	September 2014
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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