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Composite Variability Index and Propofol Remifentanil Anesthesia

NCT ID: NCT01234194

Last Updated: 2010-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

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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

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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

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Measure of Nociception

Keywords

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Composite Variability Index Bispectral Index Electromyography Nociception Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

rising remifentanil concentrations

Intervention Type DRUG

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

Group 2

Group Type ACTIVE_COMPARATOR

falling remifentanil concentrations

Intervention Type DRUG

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

Interventions

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rising remifentanil concentrations

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

Intervention Type DRUG

falling remifentanil concentrations

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing surgical procedure in general anesthesia

Exclusion Criteria

* Pregnancy, drug abuse, cardiac arrhythmia, obesity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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University of Bonn

Principal Investigators

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Richard K Ellerkmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Bonn

Locations

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University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CVI_2010

Identifier Type: -

Identifier Source: org_study_id