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Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

Primary Purpose

Spinal Induced Hypotension in Cesarean Delivery

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phenylephrine infusion
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Induced Hypotension in Cesarean Delivery

Eligibility Criteria

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

Inclusion Criteria:

  1. Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
  2. American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
  3. Age ≥ 18 years (Standard within the obstetrical literature)
  4. Term gestational age
  5. English-speaking

Exclusion Criteria:

  1. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intra-arterial catheter due to limitations in size)
  2. Height < 5'0" (Women < 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study)
  3. Laboring women
  4. Urgent or emergency cesarean delivery
  5. Hypertensive disease of pregnancy
  6. Severe maternal cardiac disease
  7. Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants
  8. Fetal anomalies or intrauterine fetal death
  9. Failed spinal anesthesia
  10. Subject enrollment in another study involving a study medication within 30 days of CD
  11. Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension
    The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 19, 2008
    Last Updated
    March 22, 2018
    Sponsor
    IWK Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00796328
    Brief Title
    Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery
    Official Title
    Up-down Determination of the ED90 of the Initial Rate of Infusion of Phenylephrine for the Prophylaxis of Spinal Induced Hypotension in Parturients Undergoing Cesarean Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Results Invalid, study closed, analysis cannot proceed.
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IWK Health Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min. The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Induced Hypotension in Cesarean Delivery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine infusion
    Intervention Description
    Up-down, biased coin design
    Primary Outcome Measure Information:
    Title
    Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension
    Description
    The effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 - 60 mcg/min.
    Time Frame
    Spinal administration until delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery) American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension) Age ≥ 18 years (Standard within the obstetrical literature) Term gestational age English-speaking Exclusion Criteria: Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study, typically have an exaggerated response to vasopressors, and the blood pressure cuff occasionally needs to be replaced by an intra-arterial catheter due to limitations in size) Height < 5'0" (Women < 5'0" are likely to require a dose of local anesthetic less than the standardized dose in this study) Laboring women Urgent or emergency cesarean delivery Hypertensive disease of pregnancy Severe maternal cardiac disease Subjects on monoamine oxidase inhibitors (MAOI's) or tricyclic antidepressants Fetal anomalies or intrauterine fetal death Failed spinal anesthesia Subject enrollment in another study involving a study medication within 30 days of CD Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

    12. IPD Sharing Statement

    Learn more about this trial

    Up-Down Determination of the ED90 of Phenylephrine for Hypotension Prophylaxis in Cesarean Delivery

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