Best Regimen for Phenylephrine Administration During Cesarean Section

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: Phenylephrine
    • phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose

Arms, Groups and Cohorts

  • Active Comparator: Phenylephrine Intermittent Bolus
    • Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).
  • Active Comparator: Phenylephrine Continuous Infusion
    • Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).

Clinical Trial Outcome Measures

Primary Measures

  • The maximum decrease in cardiac output in the pre-delivery period.
    • Time Frame: 30 minutes

Secondary Measures

  • Maximum decrease in heart rate in the pre-delivery period.
    • Time Frame: 30 minutes
  • Incidence of hypotension in the pre-delivery period (BP < 80% baseline)
    • Time Frame: 30 minutes
  • Incidence of hypertension in the pre-delivery period (BP > 120% baseline)
    • Time Frame: 30 minutes
  • Incidence of nausea and vomiting in the pre-delivery period
    • Time Frame: 30 minutes
  • Total dose of phenylephrine in the pre-delivery period
    • Time Frame: 30 minutes
  • Umbilical artery and vein blood gases
    • Time Frame: 24 hours

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  • Provider of Information About this Clinical Study
    • Dr. Jose Carvalho, Mount Sinai Hospital
  • Overall Official(s)
    • Jose Carvalho, MD, Principal Investigator, MOUNT SINAI HOSPITAL

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