Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01234194
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.
Study:
NCT01234194
Study Brief:
Protocol Section:
NCT01234194