Electroencephalogram Dynamics in Children During Different Levels of Anesthetic Depth

April 16, 2020 updated by: Claudia Spies, Charite University, Berlin, Germany
As part of the clinical routine of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM in the Charité - University Medicine Berlin intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children and adolescents according to different age groups.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

94

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
      • Berlin, Germany, 13353
        • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Belrin

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children and adolescents during anaesthesia / surgery procedure

Description

Inclusion Criteria:

  • Children and adolescents undergoing surgery procedure

Exclusion Criteria:

  • Neurosurgery
  • Pre-existing neurological conditions

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

Cohorts and Interventions

Group / Cohort
Children and adolescents
Children and adolescents for elective surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electroencephalography monitoring changes
Time Frame: Up to the end of surgery
Up to the end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Anesthetic depth
Time Frame: Up to the end of surgery
Up to the end of surgery

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

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)

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Retro-Child

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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