The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

Cerebral Palsy Clinical Trial

Official title:

The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04190082
• Other study ID #: YUMC-2019-11-001
• Status: Terminated
• Start date: May 1, 2021
• Est. completion date: December 9, 2022

Study information

• Verified date: February 2023
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation

• American Society of Anesthesiologists Physical Status 1-2

Exclusion Criteria:

• Body mass index > 30 kg/m2

• unstable heart disease

• Anticipated difficult airway including congenital facial or airway anomaly

• Recent upper respiratory tract infection ( < 2 weeks)

• Gastroesophageal reflux

• Allergy history to propofol, remifentanil or any drug used during procedure

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Korea, Republic of	Location Yeungnam University Hospita	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Propofol dose	Amount of propofol to maintain deep sedation for botulinum toxin injection	Immediately after discontinuation of propofol infusion used for botulinum toxin injection