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Composite Variability Index and Propofol Remifentanil Anesthesia

This study has been completed.
Information provided by:
University Hospital, Bonn Identifier:
First received: November 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
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 Intervention
Measure of Nociception Drug: rising remifentanil concentrations Drug: falling remifentanil concentrations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.

Resource links provided by NLM:

Further study details as provided by University Hospital, Bonn:

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

Enrollment: 24
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01234194

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

Responsible Party: Richard Klaus Ellerkmann / M.D., University of Bonn Identifier: NCT01234194     History of Changes
Other Study ID Numbers: CVI_2010
Study First Received: November 3, 2010
Last Updated: November 3, 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
Anesthetics processed this record on July 26, 2017