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Validation of a Multimodal Indicator of Depth of Anesthesia

A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02742012
Enrollment
257
Registered
2016-04-18
Start date
2015-06-30
Completion date
2017-06-30
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

electroencephalogram, hemodynamic monitoring, respiratory monitoring

Brief summary

The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28). The indicator previously developed shall now be tested on an independent set of data. The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers. The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.

Interventions

the study is observational

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age ≥ 18 years * elective surgery under general anesthesia * anticipated operating time of about one hour or longer * ASA physical status I-III * written informed consent

Exclusion criteria

* chronic intake of CNS affecting drugs * alcohol or drug abuse in the last three months * CNS or psychiatric disease * hardness of hearing or deafness * abnormal gastrointestinal motility * non-adherence to fasting guidelines, emergency surgery * anticipated difficult airway * pregnancy * cardiac surgery and surgery involving the head and/or neck * postoperatively prolonged intubation * pre- and/or postoperative intensive care treatment

Design outcomes

Primary

MeasureTime frame
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness1 minute

Secondary

MeasureTime frame
the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia1 minute

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026