Composite Variability Index Versus Bispectral Index (BIS)

Not Applicable

Completed

• Conditions: Sedation During
• Interventions: Drug: propofol + remifentanil 6 ng/ml; Drug: propofol + remifentanil 0 ng/ml; Drug: propofol + remifentanil 4 ng/ml; Drug: propofol + remifentanil 2 ng/ml

• Registration Number: NCT01053611
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

Detailed Description

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2011-03-24
• Last Update Posted: 2011-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• ASA class I and II patients requiring general anesthesia for elective surgical procedures

Exclusion Criteria

• patient refusal
• weight less than 70% or more than 130% of ideal body weight,
• neurological disorder
• recent use of psycho-active medication, including alcohol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 4 BIS value 50	propofol + remifentanil 6 ng/ml	-
Group 1 BIS value 70	propofol + remifentanil 0 ng/ml	-
Group 3 BIS value 30	propofol + remifentanil 4 ng/ml	-
Group 4 BIS valaue 30	propofol + remifentanil 6 ng/ml	-
Group 1 BIS value 30	propofol + remifentanil 0 ng/ml	-
Group 2 BIS value 30	propofol + remifentanil 2 ng/ml	-
Group 1 BIS value 50	propofol + remifentanil 0 ng/ml	-
Group 2 BIS value 50	propofol + remifentanil 2 ng/ml	-
Group 3 BIS value 50	propofol + remifentanil 6 ng/ml	-
Group 2 BIS value 70	propofol + remifentanil 2 ng/ml	-
Group 3 BIS value 70	propofol + remifentanil 4 ng/ml	-
Group 4 BIS value 70	propofol + remifentanil 6 ng/ml	-

Primary Outcome Measures

Name	Time	Method
BIS and CVI.	2 year

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands