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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.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

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
Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 30
Active Comparator group
Treatment:
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 30
Active Comparator group
Treatment:
Drug: propofol + remifentanil 4 ng/ml
Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS valaue 30
Active Comparator group
Treatment:
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 50
Active Comparator group
Treatment:
Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 50
Active Comparator group
Treatment:
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 50
Active Comparator group
Treatment:
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Group 4 BIS value 50
Active Comparator group
Treatment:
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Group 1 BIS value 70
Active Comparator group
Treatment:
Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
Group 2 BIS value 70
Active Comparator group
Treatment:
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Group 3 BIS value 70
Active Comparator group
Treatment:
Drug: propofol + remifentanil 4 ng/ml
Drug: propofol + remifentanil 4 ng/ml
Group 4 BIS value 70
Active Comparator group
Treatment:
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml
Drug: propofol + remifentanil 6 ng/ml

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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