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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Cesarean Section
Cardiac Output
Hypotension
 Drug: Phenylephrine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • The maximum decrease in cardiac output in the pre-delivery period. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phenylephrine Intermittent Bolus
Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).
 Drug: Phenylephrine
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
Active Comparator: Phenylephrine Continuous Infusion
Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).
 Drug: Phenylephrine
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996190

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose Carvalho, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00996190     History of Changes
Other Study ID Numbers: 09-03
Study First Received: October 15, 2009
Last Updated: February 22, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
transthoracic bioreactance
noninvasive monitoring
vasopressor
blood pressure

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013