Composite Variability Index and Propofol Remifentanil Anesthesia

Not Applicable

Completed

• Conditions: Measure of Nociception
• Interventions: Drug: rising remifentanil concentrations; Drug: falling remifentanil concentrations

• Registration Number: NCT01234194
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Last Update Submitted: 2010-11-03
• Study First Posted: 2010-11-04
• Last Update Posted: 2010-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients undergoing surgical procedure in general anesthesia

Exclusion Criteria

• Pregnancy, drug abuse, cardiac arrhythmia, obesity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	rising remifentanil concentrations	-
Group 2	falling remifentanil concentrations	-

Primary Outcome Measures

Name	Time	Method
Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus

Trial Locations

Locations (1)

University of Bonn; 🇩🇪 Bonn, Germany