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Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia

Primary Purpose

Intraoperative Awareness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remifentanil
Sponsored by
West China Second University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Awareness focused on measuring remifentanil, bispectral index, Caesarean delivery, general anesthesia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia

Exclusion Criteria:

  • multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Remifentanil 1 μg kg-1 (R1)

    Remifentanil 0.5 μg kg-1 (R0.5),

    saline (control)

    Arm Description

    Received remifentanil 1μg/kg when induction of general anesthesia

    Received remifentanil 0.5μg/kg when induction of general anesthesia

    Injected the equal volume normal saline when induction of general anesthesia

    Outcomes

    Primary Outcome Measures

    the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
    the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery

    Secondary Outcome Measures

    incidence of intraoperative awareness
    the maternal incidence of intraoperative awareness

    Full Information

    First Posted
    November 29, 2017
    Last Updated
    April 15, 2018
    Sponsor
    West China Second University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03508102
    Brief Title
    Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
    Official Title
    Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Second University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients undergoing caesarean delivery under inhalation anaesthesia are at a high risk of awareness, especially in the period before delivery. The investgators assessed the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
    Detailed Description
    Sixty primipara undergoing elective cesarean delivery were randomly assigned to receive remifentanil 1 μg kg-1 (R1) or 0.5 μg kg-1 (R0.5), or saline (control) over 15 s with induction of anesthesia using propofol 2 mg kg-1 and suxamethonium 1.5 mg kg-1.The investgators assessed the average value of BIS at the time period of before, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery. The investgators also determined the neonatal Apgar scores, and conducted umbilical artery blood gas analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraoperative Awareness
    Keywords
    remifentanil, bispectral index, Caesarean delivery, general anesthesia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Remifentanil 1 μg kg-1 (R1)
    Arm Type
    Experimental
    Arm Description
    Received remifentanil 1μg/kg when induction of general anesthesia
    Arm Title
    Remifentanil 0.5 μg kg-1 (R0.5),
    Arm Type
    Experimental
    Arm Description
    Received remifentanil 0.5μg/kg when induction of general anesthesia
    Arm Title
    saline (control)
    Arm Type
    No Intervention
    Arm Description
    Injected the equal volume normal saline when induction of general anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    remifentanil
    Other Intervention Name(s)
    saline
    Intervention Description
    the effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery
    Primary Outcome Measure Information:
    Title
    the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.
    Description
    the average value of BIS at the time period of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
    Time Frame
    the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
    Secondary Outcome Measure Information:
    Title
    incidence of intraoperative awareness
    Description
    the maternal incidence of intraoperative awareness
    Time Frame
    one day and one week after delivery.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia Exclusion Criteria: multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication

    12. IPD Sharing Statement

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