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

W

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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