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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234194
Enrollment
24
Registered
2010-11-04
Start date
2009-11-30
Completion date
2010-07-31
Last updated
2010-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measure of Nociception

Keywords

Composite Variability Index, Bispectral Index, Electromyography, Nociception, Pain

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.

Interventions

DRUGrising remifentanil concentrations

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

DRUGfalling remifentanil concentrations

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

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing surgical procedure in general anesthesia

Exclusion criteria

* Pregnancy, drug abuse, cardiac arrhythmia, obesity

Design outcomes

Primary

MeasureTime frame
Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026