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Completed

NCT Number: NCT01234194

Composite Variability Index and Propofol Remifentanil Anesthesia

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.

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Key information

Conditions

Measure of Nociception Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bonn

Bonn, 53115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing surgical procedure in general anesthesia

Exclusion criteria

  • Pregnancy, drug abuse, cardiac arrhythmia, obesity

Treatment and study plan

rising remifentanil concentrations

Drug

remifentanil effect-compartment concentrations 0,1,2,3 ng/ml

falling remifentanil concentrations

Drug

remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2010
Registry last updated
Nov 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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