Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391885
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2006-10-24
Brief Title:
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram Comparison Between Manual Perfusion and Automated Perfusion
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system entropy of the EEG being the controller
Detailed Description:
Several monitors are currently proposed to evaluate the depth of hypnosis Among them Bispectral Index BIS is a well known and widely used parameter derived from the patients electroencephalograph EEG A closed-loop anesthesia system can be built using BIS as the control variable a proportional-integral-differential control algorithm a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery
Spectral entropy relies on the extent of disorder in both EEG and electromyography EMG signals and returns 2 values State Entropy SE and Response Entropy SE is computed over the frequency range of 08-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 08-47 Hz and reflects also EMG activity BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE We hypothesized that SE can be used as the control variable In preparation for a large multi-center control trial we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system Two groups of patients are compared one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system In both groups the goal is to maintain SE between 40 and 60 the recommended range during anesthesia by the manufacturer We expect the combined closed-loop anesthesia system group to do similar or better
Spectral entropy relies on the extent of disorder in both EEG and electromyography EMG signals and returns 2 values State Entropy SE and Response Entropy SE is computed over the frequency range of 08-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 08-47 Hz and reflects also EMG activity BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE We hypothesized that SE can be used as the control variable In preparation for a large multi-center control trial we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system Two groups of patients are compared one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system In both groups the goal is to maintain SE between 40 and 60 the recommended range during anesthesia by the manufacturer We expect the combined closed-loop anesthesia system group to do similar or better
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None