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Completed

NCT Number: NCT04093661

Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures

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).

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Key information

Conditions

Depth of Anesthesia

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children <= 1 year undergoing surgery procedure

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Electroencephalography monitoring changes

    Time frame: 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 outcomes

  1. Anesthetic depth

    Time frame: 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.

  2. Medication

    Time frame: 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.

  3. Emergence Delirium

    Time frame: 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.

  4. Pain

    Time frame: 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 outcomes

  1. Duration of anesthesia

    Time frame: 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.

  2. Type of surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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