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Composite Variability Index Versus Bispectral Index (BIS)

2014-08-27 03:16:28 | BioPortfolio

Summary

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

Description

Patients will be allocated to recieve a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Study Design

Allocation: Randomized, Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Anesthesia

Intervention

propofol + remifentanil 0 ng/ml, propofol + remifentanil 2 ng/ml, propofol + remifentanil 4 ng/ml, propofol + remifentanil 6 ng/ml, propofol + remifentanil 0 ng/ml, propofol + remifentanil 2 ng/ml, propofol + remifentanil 6 ng/ml, propofol + remifentanil

Location

University Medical Center Groningen
Groningen
Netherlands
9713EZ

Status

Recruiting

Source

University Medical Centre Groningen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:28-0400

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Rare and often fatal drug complication which affects patients undergoing long-term treatment with high doses of PROPOFOL. It is characterized by METABOLIC ACIDOSIS; HYPERLIPIDEMIA; RHABDOMYOLYSIS; cardiovascular CIRCULATORY COLLAPSE; CARDIAC FAILURE; and KIDNEY FAILURE.

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