Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

Depth of Anesthesia Clinical Trial

Official title:

Retrospective Analysis of Intraoperative Electroencephalography Characteristics in Children Under One Year of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093661
• Other study ID #: Retro-Baby
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: January 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

• Children <= 1 year undergoing surgery procedure

Exclusion Criteria:

• Incomplete patient record documentation

• Pre-existing neurological/psychological conditions

Related Conditions & MeSH terms

• Depth of Anesthesia

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of anesthesia	Duration of anesthesia is captured from the patient records and measured until the end of surgery. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study.	06/2017 - 06/2019
Other	Type of surgery	Type of surgery is captured from the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study.	06/2017 - 06/2019
Primary	Electroencephalography monitoring changes	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.	06/2017 - 06/2019
Secondary	Anesthetic depth	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.	06/2017 - 06/2019
Secondary	Medication	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.	06/2017 - 06/2019
Secondary	Emergence Delirium	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.	06/2017 - 06/2019
Secondary	Pain	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.	06/2017 - 06/2019