Validation of a Multimodal Indicator of Depth of Anesthesia

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Anästhesiologie, Bonn, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the study is observational

Other

the study is observational

Primary outcomes

ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness

Time frame: 1 minute

Secondary outcomes

the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia

Time frame: 1 minute

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Apr 18, 2016
Registry last updated: Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed