Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-01 @ 10:02 AM
Study NCT ID:
NCT02766894
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2016-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
Sponsor:
Kepler University Hospital
Organization:
Study Overview
Official Title:
Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
Status:
COMPLETED
Status Verified Date:
2017-08
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:
Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done.
Detailed Description:
In this observational study estimation of anesthetic depth by anesthesiologists is compared with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist is included 30 times during study period. The aim of this study is to define conformity between subjective and objective assessment of narcotic depth. In the cases of divergence data of the patient (age, body mass index, comorbidity…), data of the anesthesiologist (age, years of practice…), data of anesthesia (balanced anesthesia, target controlled infusion, endtidal concentration of volatile anesthetic…) and data of the operation (eye surgery, cardiac surgery…) will be analyzed by statistics with regard to underlying or concomitant factors. These findings could help to develop recommendations in the use of EEG-processed monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to be provided for every patient.
Study Oversight
Has Oversight DMC:
False
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?: