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

Not Applicable

Completed

• Conditions: Intraoperative Awareness
• Interventions: Drug: remifentanil

• Registration Number: NCT03508102
• Lead Sponsor: West China Second University Hospital

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.

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2016-09
• Study Completion: 2017-03
• Study First Submitted: 2017-11-29
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-15
• Last Update Submitted: 2018-04-15
• Study First Posted: 2018-04-25
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil 1 μg kg-1 (R1)	remifentanil	Received remifentanil 1μg/kg when induction of general anesthesia
Remifentanil 0.5 μg kg-1 (R0.5),	remifentanil	Received remifentanil 0.5μg/kg when induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
the effects of remifentanil on the bispectral index (BIS) in the interval before delivery.	the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and 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

Name	Time	Method
incidence of intraoperative awareness	one day and one week after delivery.	the maternal incidence of intraoperative awareness