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

Tracking Information
First Submitted Date ICMJE	September 21, 2006
First Posted Date ICMJE	September 22, 2006
Last Update Posted Date	March 21, 2007
Study Start Date ICMJE	August 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 21, 2006)	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; (submitted: September 21, 2006)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; 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; (submitted: September 21, 2006)	50
Original Enrollment ICMJE	Same as current
Actual Study 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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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