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

NCT03508102 | Completed DMC

• 1 other identifier: 2015001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraoperative Awareness

Keywords

remifentanil; bispectral index; Caesarean delivery; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of intraoperative awareness

  one day and one week after delivery.

Study Arms (3)

Remifentanil 1 μg kg-1 (R1)

EXPERIMENTAL

Received remifentanil 1μg/kg when induction of general anesthesia

Drug: remifentanil

Remifentanil 0.5 μg kg-1 (R0.5),

EXPERIMENTAL

Received remifentanil 0.5μg/kg when induction of general anesthesia

Drug: remifentanil

saline (control)

NO INTERVENTION

Injected the equal volume normal saline when induction of general anesthesia

Interventions

remifentanil DRUG

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

Also known as: saline

Remifentanil 0.5 μg kg-1 (R0.5),; Remifentanil 1 μg kg-1 (R1)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I or II who elected to undergo Caesarean section, under general anaesthesia

You may not qualify if:

• multiple fetuses,preterm delivery, known fetal anomalies, pregnancy-induced hypertension, or any other medical complication

Sponsors & Collaborators

• West China Second University Hospital: lead

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Remifentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: April 25, 2018
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04