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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03508102

Enrollment

Registered

2018-04-25

Start date

2015-08-31

Completion date

2017-03-31

Last updated

2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Awareness

Keywords

remifentanil, bispectral index, Caesarean delivery, general anesthesia

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
incidence of intraoperative awareness	one day and one week after delivery.	the maternal incidence of intraoperative awareness

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026