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Composite Variability Index and Propofol Remifentanil Anesthesia

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01234194
First received: November 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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 [ Designated as safety issue: No ]

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.

  Eligibility

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

Inclusion Criteria:

  • Patients undergoing surgical procedure in general anesthesia

Exclusion Criteria:

  • Pregnancy, drug abuse, cardiac arrhythmia, obesity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234194

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

No publications provided

Responsible Party: Richard Klaus Ellerkmann / M.D., University of Bonn
ClinicalTrials.gov Identifier: NCT01234194     History of Changes
Other Study ID Numbers: CVI_2010
Study First Received: November 3, 2010
Last Updated: November 3, 2010
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 25, 2014