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Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

Primary Purpose

Hypotension, Nausea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
phenylephrine
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring spinal, Cesarean section, hypotension, nausea, vomiting, phenylephrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2006
Last Updated
March 19, 2007
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00379691
Brief Title
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section
Official Title
Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Nausea
Keywords
spinal, Cesarean section, hypotension, nausea, vomiting, phenylephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
phenylephrine
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Maternal Demographics: Maternal age-weight-height
Title
Nausea and Vomiting
Title
Time of intrathecal injection, skin incision, uterine incision, and delivery
Title
Total dose of phenylephrine
Title
Hypertension (> 120 % of baseline)
Title
Bradycardia (< 50 bpm)
Title
Upper sensory level of anesthesia by pinprick upon delivery
Title
Umbilical artery and vein blood gases

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD PhD
Organizational Affiliation
Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

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Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section

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