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NCT02742012 Clinical Trial

Validation of a Multimodal Indicator of Depth of Anesthesia

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02742012
Other study ID # AMI-1250-KIE-0250-I
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date June 2017

Study information
Verified date September 2018
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 257
Est. completion date June 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• the study is observational
the study is observational

Locations
Country Name City State
Germany Klinik für Anästhesiologie Bonn
Germany Klinikum rechts der Isar, Department of Anesthesiology Munich
Germany Klinik für Anästhesiologie am Helios Klinikum Wuppertal

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness 1 minute
Secondary the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia 1 minute
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