Back to resultsEffect 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
About this trial
This is an interventional prevention trial for Intraoperative Awareness focused on measuring remifentanil, bispectral index, Caesarean delivery, general anesthesia
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
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
NCT ID
NCT03508102
First Posted
November 29, 2017
Last Updated
April 15, 2018
Sponsor
West China Second University Hospital
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
Learn more about this trial
Effect of Remifentanil on the Bispectral Index in Women Undergoing Caesarean Delivery Under General Anaesthesia
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