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

NCT02766894 | Completed

• 1 other identifier: C-109-16
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.

  Depth of anesthesia will be assessed by the anesthesiologist in an subjective way. During a defined period of stable anesthesia state, the indicated subjective depth levels will be assessed by the anesthesiologist and will be compared to those obtained by narcotrend (Narcotrend-Index). Anesthesiologists will assess by deep, moderate and superficial depth of anesthesia. Narcotrend indices will also be assigned to three groups (superficial, moderate, deep levels). After the procedure, both systems will be compared. In the case of non-correlation, other factors like i.e. patient's age, comorbidities, years of practice of the anesthesiologist etc. will be analysed for any other type of correlation.

  up to 1 year

Interventions

EEG monitoring DEVICE

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

Eligibility Criteria

• Age: 1 Year - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kepler University Hospital: lead

Related Publications (3)

• 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.

  PMID: 16037157 BACKGROUND

• 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.

  PMID: 15064250 BACKGROUND

• 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.

  PMID: 32128723 DERIVED

Study Officials

• Jens Meier, MD, PhD

  Kepler UH, Dept. of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 10, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share