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Completed

NCT Number: NCT03079362

SDR Monitoring in Children With Cerebral Palsy

The study evaluates the anatomical distribution of the assessed Electromyogram (EMG) responses ensuring after sensory nerve root stimulation and obtained IOM grading during selective dorsal rhizotomy (SDR) with regard to level and, side of the body and gender as well as pain management and outcome data.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female children with spastic cerebral palsy undergoing selective dorsal rhizotomy surgery including intraoperative neuromonitoring

Exclusion criteria

  • > 21 years

Treatment and study plan

Primary outcomes

  1. The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure

    Time frame: During the operation

Secondary outcomes

  1. Intensive care unit length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day

  2. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  3. Ready to discharge

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Measured Pads-Score

  4. Duration of ventilation

    Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day

    Measured in days and hours

  5. Pain

    Time frame: Up to 12 months

    Measured by scales

  6. Organ complications

    Time frame: Up to 12 months

  7. Adverse reactions of pain therapy

    Time frame: Up to 12 months

  8. Therapy of adverse reactions of pain therapy

    Time frame: Up to 12 months

  9. Infections

    Time frame: Up to 12 months

  10. Delirium

    Time frame: Up to 12 months

    Measured by Nu-DESC

  11. Routine laboratory

    Time frame: Up to 12 months

  12. Pain therapy

    Time frame: Up to 12 months

  13. Temperature

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  14. Satisfaction with pain therapy

    Time frame: Up to 12 months

    Rating scale

  15. Positional control of epiperidural catheter

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

  16. Reoperations

    Time frame: Up to 12 months

  17. Gross motor function measure

    Time frame: Up to 12 months

  18. Gait analysis instrumented three dimensional

    Time frame: Up to 12 months

  19. Strength

    Time frame: Up to 12 months

  20. Spasticity

    Time frame: Up to 12 months

  21. Range of motion

    Time frame: Up to 12 months

  22. Gait

    Time frame: Up to 12 months

  23. Functions scores

    Time frame: Up to 12 months

  24. Gross motor function classification system

    Time frame: Up to 12 months

  25. Modified Ashworth Scale

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

SDR Monitoring in Children With Cerebral Palsy - a Retrospective Cohort Study

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Mar 14, 2017
Registry last updated
Jan 4, 2018

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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