Composite Variability Index Versus Bispectral Index (BIS)

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Sedation During

Treatments

Drug: propofol + remifentanil 4 ng/ml

Drug: propofol + remifentanil 2 ng/ml

Drug: propofol + remifentanil 0 ng/ml

Drug: propofol + remifentanil 6 ng/ml

Study type

Interventional

Funder types

Other

Identifiers

NCT01053611

2009.083

Details and patient eligibility

About

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).

Full 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

140 participants in 12 patient groups

Group 1 BIS value 30

Active Comparator group

Treatment:

Drug: propofol + remifentanil 0 ng/ml

Group 2 BIS value 30

Active Comparator group

Treatment:

Drug: propofol + remifentanil 2 ng/ml

Group 3 BIS value 30

Active Comparator group

Treatment:

Drug: propofol + remifentanil 4 ng/ml

Group 4 BIS valaue 30

Active Comparator group

Treatment:

Drug: propofol + remifentanil 6 ng/ml

Group 1 BIS value 50

Active Comparator group

Treatment:

Drug: propofol + remifentanil 0 ng/ml

Group 2 BIS value 50

Active Comparator group

Treatment:

Drug: propofol + remifentanil 2 ng/ml

Group 3 BIS value 50

Active Comparator group

Treatment:

Drug: propofol + remifentanil 6 ng/ml

Group 4 BIS value 50

Active Comparator group

Treatment:

Drug: propofol + remifentanil 6 ng/ml

Group 1 BIS value 70

Active Comparator group

Treatment:

Drug: propofol + remifentanil 0 ng/ml

Group 2 BIS value 70

Active Comparator group

Treatment:

Drug: propofol + remifentanil 2 ng/ml

Group 3 BIS value 70

Active Comparator group

Treatment:

Drug: propofol + remifentanil 4 ng/ml

Group 4 BIS value 70

Active Comparator group

Treatment:

Drug: propofol + remifentanil 6 ng/ml

Trial contacts and locations

1

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