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Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

Primary Purpose

Anesthetic Complication Spinal

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Phenylephrine
saline
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthetic Complication Spinal focused on measuring spinal, cesarean delivery, phenylephrine, hypotension

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Parturients beyond 37 weeks gestation
  • ASA І or ІІ

Exclusion Criteria:

  • pregnancy-induced hypertension
  • chronic hypertension
  • multiple pregnancy
  • fetal compromise
  • diabetes mellitus
  • polyhydramnios
  • body weight >100 kg
  • major systemic disease
  • anemia (hemoglobin concentration<10 g/dl)
  • clotting diathesis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Phenylephrine

    Saline

    Arm Description

    PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery

    Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline

    Outcomes

    Primary Outcome Measures

    Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
    Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: stopping the phenylephrine infusion changing the rate of phenylephrine infusion rescue intravenous bolus of phenylephrine (100 µg) for hypotension rescue intravenous bolus of atropine (0.4 mg) for bradycardia

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2011
    Last Updated
    August 11, 2014
    Sponsor
    American University of Beirut Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01378325
    Brief Title
    Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery
    Official Title
    Crystalloid Coload Combined With Variable Rate Phenylephrine Infusion for Prevention of Hypotension During Spinal Anesthesia for Elective Cesarean Delivery vs Crystalloid Coload Alone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    American University of Beirut Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload). Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming. Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups. We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthetic Complication Spinal
    Keywords
    spinal, cesarean delivery, phenylephrine, hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phenylephrine
    Arm Type
    Experimental
    Arm Description
    PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Other Intervention Name(s)
    Neosynephrine
    Intervention Description
    Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
    Intervention Type
    Drug
    Intervention Name(s)
    saline
    Intervention Description
    Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
    Primary Outcome Measure Information:
    Title
    Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
    Description
    Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: stopping the phenylephrine infusion changing the rate of phenylephrine infusion rescue intravenous bolus of phenylephrine (100 µg) for hypotension rescue intravenous bolus of atropine (0.4 mg) for bradycardia
    Time Frame
    Patients will be followed up throughout the Cesarean delivery (average of 1.5 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: Parturients beyond 37 weeks gestation ASA І or ІІ Exclusion Criteria: pregnancy-induced hypertension chronic hypertension multiple pregnancy fetal compromise diabetes mellitus polyhydramnios body weight >100 kg major systemic disease anemia (hemoglobin concentration<10 g/dl) clotting diathesis

    12. IPD Sharing Statement

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    Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery

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