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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraoperative Awareness

Intervention / Treatment
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* Drug: remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil 1 μg kg-1 (R1)<br>Received remifentanil 1μg/kg when induction of general anesthesia | Drug: remifentanil<br>* 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<br>* Other names: saline;|
| Experimental: Remifentanil 0.5 μg kg-1 (R0.5),<br>Received remifentanil 0.5μg/kg when induction of general anesthesia | Drug: remifentanil<br>* 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<br>* Other names: saline;|
| No Intervention: saline (control)<br>Injected the equal volume normal saline when induction of general anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of intraoperative awareness | the maternal incidence of intraoperative awareness | one day and one week after delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remifentanil, bispectral index, Caesarean delivery, general anesthesia