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Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

Primary Purpose

Adverse Anesthesia Outcome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
phenylephrine
Norepinephrine
Bupivacaine
Fentanyl
Placebo (normal saline)
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adverse Anesthesia Outcome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • full term singleton parturients
  • elective cesarean sections

Exclusion Criteria:

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • body mass index > 35 will be excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    phenylephrine,

    norepinephrine

    Arm Description

    - Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.

    - Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.

    Outcomes

    Primary Outcome Measures

    Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)

    Secondary Outcome Measures

    systolic and diastolic blood pressures measured in mm Hg
    heart rate measured in beats per minute
    nausea and vomiting measured in number of attacks

    Full Information

    First Posted
    December 5, 2016
    Last Updated
    May 1, 2017
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03015857
    Brief Title
    Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
    Official Title
    A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.
    Detailed Description
    On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position. After spinal block, patients will be randomly allocated into one of two groups: Phenylephrine group (n=100) Norepinephrine group (n=100) Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Anesthesia Outcome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    phenylephrine,
    Arm Type
    Active Comparator
    Arm Description
    - Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
    Arm Title
    norepinephrine
    Arm Type
    Active Comparator
    Arm Description
    - Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
    Intervention Type
    Drug
    Intervention Name(s)
    phenylephrine
    Intervention Description
    - phenylephrine; a vasopressor drug given to prevent post spinal hypotension
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine
    Intervention Description
    - norepinephrine; a vasopressor drug given to prevent post spinal hypotension
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    intrathecal bupivacaine 10 mg will be given in both groups
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    intrathecal fentanyl 20 mcg will be given in both groups
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (normal saline)
    Primary Outcome Measure Information:
    Title
    Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    systolic and diastolic blood pressures measured in mm Hg
    Time Frame
    2 hours
    Title
    heart rate measured in beats per minute
    Time Frame
    2 hours
    Title
    nausea and vomiting measured in number of attacks
    Time Frame
    2 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: full term singleton parturients elective cesarean sections Exclusion Criteria: cardiac morbidities hypertensive disorders of pregnancy peripartum bleeding body mass index > 35 will be excluded from the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shereen Refaat, M.D.
    Organizational Affiliation
    Lecturer of anesthesia Faculty of medicine Cairo university
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Tamer M Rook, M.D.
    Organizational Affiliation
    Lecturer of anesthesia Faculty of medicine Cairo university
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

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