Composite Variability Index Versus Bispectral Index (BIS)

Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053611

Enrollment

140

Registered

2010-01-21

Start date

2009-09-30

Completion date

2010-09-30

Last updated

2011-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation During

Keywords

composite variability index, bispectral index, pain

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.

Interventions

DRUGpropofol + remifentanil 0 ng/ml

remifentanil 0 ng/ml

DRUGpropofol + remifentanil 2 ng/ml

DRUGpropofol + remifentanil 4 ng/ml

DRUGpropofol + remifentanil 6 ng/ml

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
BIS and CVI.	2 year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026