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

Intraoperative Awareness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508102
• Other study ID #: 2015001
• Status: Completed
• Phase: N/A
• First received: November 29, 2017
• Last updated: April 15, 2018
• Start date: August 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: West China Second University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Awareness

Intervention

Drug:
• remifentanil
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the time of before induction, induction , intubation, skin incision, peritoneum incision , uterine incision , and delivery
Secondary	incidence of intraoperative awareness	the maternal incidence of intraoperative awareness	one day and one week after delivery.