Validation of a Multimodal Indicator of Depth of Anesthesia

September 10, 2018 updated by: Andreas Ranft, Technical University of Munich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Klinik für Anästhesiologie
      • Munich, Germany, 81675
        • Klinikum rechts der Isar, Department of Anesthesiology
      • Wuppertal, Germany, 42283
        • Klinik für Anästhesiologie am Helios Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

250 adult patients scheduled for elective surgery under general anesthesia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
Time Frame: 1 minute
1 minute

Secondary Outcome Measures

Outcome Measure
Time Frame
the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia
Time Frame: 1 minute
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Chair: Eberhard F Kochs, MD, Klinikum rechts der Isar Technische Universität München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMI-1250-KIE-0250-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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