Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EEG monitoring

EEG will be performed. Data obtained will be analyzed using software. Anesthesiologists will enter their assumption in a blinded fashion and data obtained will be compared with EEG data

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* operation under general anesthesia
* duration of surgery ≥ 10 minutes
* informed consent
* ASA physical status 1-4
* age 1-110y
* performance check of Narcotrend

Exclusion Criteria

* proximity of EEG electrodes to the operating field
* frontal skin lesion
* frontal cerebral pathology
* hypoxic brain damage
* hypothermia (≤33°C)
* language barrier

Minimum Eligible Age

1 Year

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No