Composite Variability Index and Propofol Remifentanil Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234194
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : November 4, 2010
Information provided by:
University Hospital, Bonn

Brief Summary:
The purpose of the study is to determine if the new Composite Variability Index (CVI) is capable of detecting changing effect compartment concentrations of remifentanil. In addition, it is planed to detect if the change in CVI in response to a standardized painful stimulus is dose-dependent.

Condition or disease Intervention/treatment Phase
Measure of Nociception Drug: rising remifentanil concentrations Drug: falling remifentanil concentrations Not Applicable

Detailed Description:

On the day of surgery, patients receive anesthesia by propofol infusion. As soon as the patient is unresponsive und unconscious (BIS 40-60) and a steady state is achieved, a standardized painful stimulus is applied by electrical stimulation of the ulnar nerve (tetanic stimulation [70 mA], 30 seconds, 50 Hz) in group 1. Thereafter remifentanil is infused to an effect compartment concentration target of 1 ng/ml. The standardized stimulus is applied again as the remifentanil target is reached. This procedure is repeated with remifentanil targets of 2 ng/ml and 3ng/ml. In group 2 remifentanil is targeted to effect compartment concentrations of 3 ng/ml followed by 2,1, and 0 ng/ml.

After measuring the effect of the last painful stimulus the patient is intubated for surgery. Throughout the study the Composite Variability Index and standard monitoring is recorded.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1 Drug: rising remifentanil concentrations
remifentanil effect-compartment concentrations 0,1,2,3 ng/ml
Active Comparator: Group 2 Drug: falling remifentanil concentrations
remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml

Primary Outcome Measures :
  1. Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing surgical procedure in general anesthesia

Exclusion Criteria:

  • Pregnancy, drug abuse, cardiac arrhythmia, obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01234194

University of Bonn
Bonn, Germany, 53115
Sponsors and Collaborators
University Hospital, Bonn
Principal Investigator: Richard K Ellerkmann, M.D. University of Bonn

Responsible Party: Richard Klaus Ellerkmann / M.D., University of Bonn Identifier: NCT01234194     History of Changes
Other Study ID Numbers: CVI_2010
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: September 2010

Keywords provided by University Hospital, Bonn:
Composite Variability Index
Bispectral Index

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