Clinical trial NCT02766894: Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
Official title: Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients:

Randomization of patients (m/w) after informed consent. For detailed inclusion criteria see corresponding section.

Patients are randomly assigned to anesthesiologist. Anesthesiologists are blinded and must assume anesthesia level. Evaluation will be performed by study leader.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kepler UH, Dept. of Anesthesiology
name: Jens Meier, MD, PhD
role: STUDY_CHAIR
References:
citation: Kreuer S, Bruhn J, Stracke C, Aniset L, Silomon M, Larsen R, Wilhelm W. Narcotrend or bispectral index monitoring during desflurane-remifentanil anesthesia: a comparison with a standard practice protocol. Anesth Analg. 2005 Aug;101(2):427-434. doi: 10.1213/01.ANE.0000157565.00359.E2.
citation: Bauerle K, Greim CA, Schroth M, Geisselbrecht M, Kobler A, Roewer N. Prediction of depth of sedation and anaesthesia by the Narcotrend EEG monitor. Br J Anaesth. 2004 Jun;92(6):841-5. doi: 10.1093/bja/aeh142. Epub 2004 Apr 2.
citation: Puchner WF, Dunser MW, Paulus P, Neuner MP, Mayer CL, Pomberger IM, Hackl R, Meier JM. A comparative study on adequate anesthesia depth: clinical judgement and the Narcotrend(R) measurement. Can J Anaesth. 2020 Jun;67(6):664-673. doi: 10.1007/s12630-020-01602-x. Epub 2020 Mar 3.