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No more participants enrolled.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Control | Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score. | ||
| Group BIS | Group who maintain deep sedation using Bispectral Index (BIS) score. |
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| Measure | Description | Time Frame |
|---|---|---|
| recovery | Time taken to recover based on the Physiological CBD score (>12) from deep sedation | Immediately after discontinuation of propofol infusion used for botulinum toxin injection |
| Measure | Description | Time Frame |
|---|---|---|
| Propofol dose | Amount of propofol to maintain deep sedation for botulinum toxin injection | Immediately after discontinuation of propofol infusion used for botulinum toxin injection |
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Inclusion Criteria:
Exclusion Criteria:
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children with spastic cerebral palsy primary care clinic (rehabilitation)
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| Name | Affiliation | Role |
|---|---|---|
| Sung Mee Jung, MD,PhD | Yeungnam University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Location Yeungnam University Hospita | Daegu | 42415 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12456420 | Result | Choudhry DK, Brenn BR. Bispectral index monitoring: a comparison between normal children and children with quadriplegic cerebral palsy. Anesth Analg. 2002 Dec;95(6):1582-5, table of contents. doi: 10.1097/00000539-200212000-00020. | |
| 16428530 | Result | Malviya S, Voepel-Lewis T, Tait AR. A comparison of observational and objective measures to differentiate depth of sedation in children from birth to 18 years of age. Anesth Analg. 2006 Feb;102(2):389-94. doi: 10.1213/01.ANE.0000184045.01780.73. |
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no plan to share our data
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 16324022 | Result | Saricaoglu F, Celebi N, Celik M, Aypar U. The evaluation of propofol dosage for anesthesia induction in children with cerebral palsy with bispectral index (BIS) monitoring. Paediatr Anaesth. 2005 Dec;15(12):1048-52. doi: 10.1111/j.1460-9592.2005.01658.x. |