Clinical trial NCT03079362: SDR Monitoring in Children With Cerebral Palsy
Official title: SDR Monitoring in Children With Cerebral Palsy - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 148
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female pediatric and adolescent patients undergoing SDR

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \> 21 years

Primary outcomes:
measure: The frequency distribution pattern of the grading assessed by SDR monitoring Electromyogram (EMG) procedure
timeFrame: During the operation
Secondary outcomes:
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Ready to discharge
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Duration of ventilation
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 1 day
measure: Pain
timeFrame: Up to 12 months
measure: Organ complications
timeFrame: Up to 12 months
measure: Adverse reactions of pain therapy
timeFrame: Up to 12 months
measure: Therapy of adverse reactions of pain therapy
timeFrame: Up to 12 months
measure: Infections
timeFrame: Up to 12 months
measure: Delirium
timeFrame: Up to 12 months
measure: Routine laboratory
timeFrame: Up to 12 months
measure: Pain therapy
timeFrame: Up to 12 months
measure: Temperature
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Satisfaction with pain therapy
timeFrame: Up to 12 months
measure: Positional control of epiperidural catheter
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Reoperations
timeFrame: Up to 12 months
measure: Gross motor function measure
timeFrame: Up to 12 months
measure: Gait analysis instrumented three dimensional
timeFrame: Up to 12 months
measure: Strength
timeFrame: Up to 12 months
measure: Spasticity
timeFrame: Up to 12 months
measure: Range of motion
timeFrame: Up to 12 months
measure: Gait
timeFrame: Up to 12 months
measure: Functions scores
timeFrame: Up to 12 months
measure: Gross motor function classification system
timeFrame: Up to 12 months
measure: Modified Ashworth Scale
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité University Medicine -Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Wolter S, Spies C, Martin JH, Schulz M, Sarpong-Bengelsdorf A, Unger J, Thomale UW, Michael T, Murphy JF, Haberl H. Frequency distribution in intraoperative stimulation-evoked EMG responses during selective dorsal rhizotomy in children with cerebral palsy-part 1: clinical setting and neurophysiological procedure. Childs Nerv Syst. 2020 Sep;36(9):1945-1954. doi: 10.1007/s00381-020-04734-z. Epub 2020 Jun 23.