Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

Completed

• Conditions: Depth of Anesthesia

• Registration Number: NCT04093661
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\<=1 year).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Children <= 1 year undergoing surgery procedure

Exclusion Criteria

• Incomplete patient record documentation
• Pre-existing neurological/psychological conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electroencephalography monitoring changes	06/2017 - 06/2019	The primary objective of this study performed according to an observational post-ad-hoc design measures the perioperative EEG overall power signature. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charité will be enrolled in the study. They are followed up until their discharge from the recovery room.

Secondary Outcome Measures

Name	Time	Method
Emergence Delirium	06/2017 - 06/2019	Delirium is captured form the PAED Score data in the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.
Anesthetic depth	06/2017 - 06/2019	Anesthetic stage is related to typical time points during an anesthetic procedure - as "loss of consciousness", "intubation", "stable anesthesia", "extubation", "regain of consciousness". Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.
Pain	06/2017 - 06/2019	Pain scores are captured form the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.
Medication	06/2017 - 06/2019	Medication data are captured from the patient sheets. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.

Trial Locations

Locations (1)

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany