Composite Variability Index Versus Bispectral Index (BIS)

March 24, 2011 updated by: University Medical Center Groningen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713EZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1 BIS value 30
Drug: propofol + remifentanil 0 ng/ml
remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
ACTIVE_COMPARATOR: Group 2 BIS value 30
Drug: propofol + remifentanil 2 ng/ml
ACTIVE_COMPARATOR: Group 3 BIS value 30
Drug: propofol + remifentanil 4 ng/ml
ACTIVE_COMPARATOR: Group 4 BIS valaue 30
Drug: propofol + remifentanil 6 ng/ml
ACTIVE_COMPARATOR: Group 1 BIS value 50
Drug: propofol + remifentanil 0 ng/ml
remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
ACTIVE_COMPARATOR: Group 2 BIS value 50
Drug: propofol + remifentanil 2 ng/ml
ACTIVE_COMPARATOR: Group 3 BIS value 50
Drug: propofol + remifentanil 6 ng/ml
ACTIVE_COMPARATOR: Group 4 BIS value 50
Drug: propofol + remifentanil 6 ng/ml
ACTIVE_COMPARATOR: Group 1 BIS value 70
Drug: propofol + remifentanil 0 ng/ml
remifentanil 0 ng/ml
Drug: propofol + remifentanil 0 ng/ml
ACTIVE_COMPARATOR: Group 2 BIS value 70
Drug: propofol + remifentanil 2 ng/ml
ACTIVE_COMPARATOR: Group 3 BIS value 70
Drug: propofol + remifentanil 4 ng/ml
ACTIVE_COMPARATOR: Group 4 BIS value 70
Drug: propofol + remifentanil 6 ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BIS and CVI.
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2011

Last Update Submitted That Met QC Criteria

March 24, 2011

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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