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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766894
• Other study ID #: C-109-16
• Status: Completed
• Phase: N/A
• First received: May 1, 2016
• Last updated: August 17, 2017
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Kepler University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kepler University Hospital

References & Publications (2)

Bauerle K, Greim CA, Schroth M, Geisselbrecht M, Köbler A, Roewer N. Prediction of depth of sedation and anaesthesia by the Narcotrend EEG monitor. Br J Anaesth. 2004 Jun;92(6):841-5. Epub 2004 Apr 2. Erratum in: Br J Anaesth. 2004 Jun;92(6):912. — View 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):427-34, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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