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

West China Second University Hospital

Status: Completed

Conditions: Intraoperative Awareness

Treatments: Drug: remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03508102

2015001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Remifentanil 1 μg kg-1 (R1)

Experimental group

Description:

Received remifentanil 1μg/kg when induction of general anesthesia

Treatment:

Drug: remifentanil

Remifentanil 0.5 μg kg-1 (R0.5),

Experimental group

Description:

Received remifentanil 0.5μg/kg when induction of general anesthesia

Treatment:

Drug: remifentanil

saline (control)

No Intervention group

Description:

Injected the equal volume normal saline when induction of general anesthesia