Clinical Trials Directory

Trials / Completed

CompletedNCT02766894

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

Status
Completed
Phase
Study type
Observational
Enrollment
600 (actual)
Sponsor
Kepler University Hospital · Academic / Other
Sex
All
Age
1 Year – 110 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEEG monitoringEEG 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

Timeline

Start date
2016-05-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2016-05-10
Last updated
2017-08-22

Source: ClinicalTrials.gov record NCT02766894. Inclusion in this directory is not an endorsement.