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Best Regimen for Phenylephrine Administration During Cesarean Section

Primary Purpose

Cesarean Section, Cardiac Output, Hypotension

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring transthoracic bioreactance, noninvasive monitoring, vasopressor, blood pressure

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phenylephrine Intermittent Bolus

Phenylephrine Continuous Infusion

Arm Description

Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).

Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).

Outcomes

Primary Outcome Measures

The maximum decrease in cardiac output in the pre-delivery period.

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2009
Last Updated
February 22, 2011
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00996190
Brief Title
Best Regimen for Phenylephrine Administration During Cesarean Section
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Cardiac Output, Hypotension
Keywords
transthoracic bioreactance, noninvasive monitoring, vasopressor, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenylephrine Intermittent Bolus
Arm Type
Active Comparator
Arm Description
Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).
Arm Title
Phenylephrine Continuous Infusion
Arm Type
Active Comparator
Arm Description
Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
Primary Outcome Measure Information:
Title
The maximum decrease in cardiac output in the pre-delivery period.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Maximum decrease in heart rate in the pre-delivery period.
Time Frame
30 minutes
Title
Incidence of hypotension in the pre-delivery period (BP < 80% baseline)
Time Frame
30 minutes
Title
Incidence of hypertension in the pre-delivery period (BP > 120% baseline)
Time Frame
30 minutes
Title
Incidence of nausea and vomiting in the pre-delivery period
Time Frame
30 minutes
Title
Total dose of phenylephrine in the pre-delivery period
Time Frame
30 minutes
Title
Umbilical artery and vein blood gases
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

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Best Regimen for Phenylephrine Administration During Cesarean Section

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