Text Size

Composite Variability Index Versus Bispectral Index (BIS)

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01053611
First received: January 20, 2010
Last updated: March 24, 2011
Last verified: September 2009
History of Changes
  Purpose

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).


Condition Intervention
Sedation During
 Drug: propofol + remifentanil 0 ng/ml
Drug: propofol + remifentanil 2 ng/ml
Drug: propofol + remifentanil 4 ng/ml
Drug: propofol + remifentanil 6 ng/ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • BIS and CVI. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 BIS value 30 Drug: propofol + remifentanil 0 ng/ml
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
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053611

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713EZ
Sponsors and Collaborators
University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: M.M.R.F.Struys, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01053611     History of Changes
Other Study ID Numbers: 2009.083
Study First Received: January 20, 2010
Last Updated: March 24, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
composite variability index
bispectral index
pain

Additional relevant MeSH terms:
Propofol
Remifentanil
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013