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

September 21, 2006
March 19, 2007
August 2006
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00379691 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section
Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Hypotension
  • Nausea
Drug: phenylephrine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2006
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00379691
06-01, 06-0186-E
No
Not Provided
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD PhD Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
March 2007

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