Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

This study has been completed.

Sponsor:

Information provided by:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

ClinicalTrials.gov Identifier:

NCT00379691

First received: September 21, 2006

Last updated: March 19, 2007

Last verified: March 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2006

Last Updated Date

March 19, 2007

Start Date ^ICMJE

August 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The primary outcome will be the minimum dose of phenylephrine which effectively prevents both hypotension and nausea/vomiting between intrathecal injection of the local anesthetic and delivery of the fetus.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00379691 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maternal Demographics: Maternal age-weight-height
Nausea and Vomiting
Time of intrathecal injection, skin incision, uterine incision, and delivery
Total dose of phenylephrine
Hypertension (> 120 % of baseline)
Bradycardia (< 50 bpm)
Upper sensory level of anesthesia by pinprick upon delivery
Umbilical artery and vein blood gases

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

Official Title ^ICMJE

Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section

Brief Summary

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in Cesarean section in 95 % of our patients. An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

Detailed Description

The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be conducted in a randomized double-blinded fashion. This dose-response study will be conducted as per the up-down sequential allocation method, modified by the Narayana rule, designed to cluster the results around the ED95.

Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. Phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.Hypotension will be defined as a SBP less than 80 % of the baseline value, in which case the treatment will be a failure. Hypertension will be defined as a SBP more than 120 % of baseline value. If a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.

The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Hypotension
Nausea

Intervention ^ICMJE

Drug: phenylephrine

Study Arms

Not Provided

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

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elective CS under spinal anesthesia
Normal singleton pregnancy beyond 36 weeks gestation
ASA physical status I/II
Weight 50-100 kg, height 150-180 cm
Age over 18 years

Exclusion Criteria:

Patient refusal
Allergy or hypersensitivity to phenylephrine
Preexisting or pregnancy-induced hypertension
Cardiovascular or cerebrovascular disease
Fetal abnormalities
History of diabetes, excluding gestational diabetes

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00379691

Other Study ID Numbers ^ICMJE

06-01
06-0186-E

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jose CA Carvalho, MD PhD

Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto

PRS Account

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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