Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04093661

Enrollment

125

Registered

2019-09-18

Start date

2019-09-16

Completion date

2019-11-29

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depth of Anesthesia

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

Healthy volunteers

Inclusion criteria

• Children \<= 1 year undergoing surgery procedure

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Other

Measure	Time frame	Description
Duration of anesthesia	06/2017 - 06/2019	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.
Type of surgery	06/2017 - 06/2019	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.

Countries

Germany

Outcome results