Composite Variability Index and Propofol Remifentanil Anesthesia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Measure of Nociception |
Drug: rising remifentanil concentrations Drug: falling remifentanil concentrations |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Changes in the Composite Variability Index in Response to Different Remifentanil Concentrations and Standardized Painful Stimuli. |
- Prediction Probability of CVI versus remifentanil effect compartment concentration and versus movement after painful stimulus [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Group 1 |
Drug: rising remifentanil concentrations
remifentanil effect-compartment concentrations 0,1,2,3 ng/ml
|
| Active Comparator: Group 2 |
Drug: falling remifentanil concentrations
remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing surgical procedure in general anesthesia
Exclusion Criteria:
- Pregnancy, drug abuse, cardiac arrhythmia, obesity
Contacts and Locations More Information
No publications provided
| Responsible Party: | Richard Klaus Ellerkmann / M.D., University of Bonn |
| ClinicalTrials.gov Identifier: | NCT01234194 History of Changes |
| Other Study ID Numbers: | CVI_2010 |
| Study First Received: | November 3, 2010 |
| Last Updated: | November 3, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital, Bonn:
|
Composite Variability Index Bispectral Index Electromyography Nociception Pain |
Additional relevant MeSH terms:
|
Remifentanil Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013