NCT01234194

Composite Variability Index and Propofol Remifentanil Anesthesia

Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Measure of Nociception

Interventions

Type	Name	Description
DRUG	rising remifentanil concentrations	remifentanil effect-compartment concentrations 0,1,2,3 ng/ml
DRUG	falling remifentanil concentrations	remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-11-04
• Last updated: 2010-11-04

Locations

1 site across 1 country: Germany