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CompletedNCT03508102Updated Apr 25, 2018

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

An interventional study of remifentanil in Intraoperative Awareness, sponsored by West China Second University Hospital. Completed. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by West China Second University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Aug 2015, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Intraoperative Awareness

Keywords

  • remifentanil
  • bispectral index
  • Caesarean delivery
  • general anesthesia
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In context

Intraoperative Awareness

51 studies on the registry are indexed under Intraoperative Awareness; 7 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 25 interventional studies indexed under Intraoperative Awareness.

Browse Intraoperative Awareness studies →

Lead sponsor

West China Second University Hospital is the lead sponsor of 37 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Remifentanil 1 μg kg-1 (R1)

    Received remifentanil 1μg/kg when induction of general anesthesia

    Drug: remifentanil

  • Experimental
    Remifentanil 0.5 μg kg-1 (R0.5),

    Received remifentanil 0.5μg/kg when induction of general anesthesia

    Drug: remifentanil

  • No intervention
    saline (control)

    Injected the equal volume normal saline when induction of general anesthesia

Interventions

  • Drugremifentanil

    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

    Also known as: saline

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What researchers measure

Primary outcomes

  1. 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

    Time frame: the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery

Secondary outcomes

  1. incidence of intraoperative awareness

    the maternal incidence of intraoperative awareness

    Time frame: one day and one week after delivery.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03508102
Lead sponsor
West China Second University Hospital
Responsible party
Qing Zhu (attending physician, West China Second University Hospital) — Principal investigator
First posted
Apr 25, 2018
Start date
Aug 2015
Primary completion
Sep 2016
Completion
Mar 2017
Last update
Apr 25, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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