An observational study in Cerebral Palsy, sponsored by Yeungnam University College of Medicine. Terminated at 1 site in Korea, Republic of. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Yeungnam University College of Medicine · Observational
The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.
After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 12 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
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children with spastic cerebral palsy primary care clinic (rehabilitation)
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score.
Group who maintain deep sedation using Bispectral Index (BIS) score.
recovery
Time taken to recover based on the Physiological CBD score (\>12) from deep sedation
Time frame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Propofol dose
Amount of propofol to maintain deep sedation for botulinum toxin injection
Time frame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Plan to share: No — no plan to share our data
Ran from May 2021 to primary completion in Dec 2022, 19 months.
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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Yeungnam University College of Medicine