Best Regimen for Phenylephrine Administration During Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00996190
First received: October 15, 2009
Last updated: February 22, 2011
Last verified: February 2011

October 15, 2009
February 22, 2011
November 2009
August 2010   (final data collection date for primary outcome measure)
The maximum decrease in cardiac output in the pre-delivery period. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996190 on ClinicalTrials.gov Archive Site
  • Maximum decrease in heart rate in the pre-delivery period. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Incidence of hypotension in the pre-delivery period (BP < 80% baseline) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Incidence of hypertension in the pre-delivery period (BP > 120% baseline) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Incidence of nausea and vomiting in the pre-delivery period [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Total dose of phenylephrine in the pre-delivery period [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Umbilical artery and vein blood gases [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Best Regimen for Phenylephrine Administration During Cesarean Section
Study to Determine the Best Regimen for Administration of Phenylephrine During Spinal Anesthesia for Cesarean Delivery, as Determined by Maternal Blood Pressure and Cardiac Output

During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.

Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.

In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.

The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cesarean Section
  • Cardiac Output
  • Hypotension
Drug: Phenylephrine
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
  • Active Comparator: Phenylephrine Intermittent Bolus
    Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).
    Intervention: Drug: Phenylephrine
  • Active Comparator: Phenylephrine Continuous Infusion
    Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).
    Intervention: Drug: Phenylephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to communicate in English
  • Elective Cesarean Delivery 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
  • Inability to communicate in English
  • Allergy or hypersensitivity to phenylephrine
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • History of diabetes, excluding gestational diabetes
  • Contra-indications for spinal anesthesia
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00996190
09-03
No
Dr. Jose Carvalho, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose Carvalho, MD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
February 2011

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