The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation

Terminated

• Conditions: Cerebral Palsy

• Registration Number: NCT04190082
• Lead Sponsor: Yeungnam University College of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-09
• Study Start: 2021-05-01
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recovery	Immediately after discontinuation of propofol infusion used for botulinum toxin injection	Time taken to recover based on the Physiological CBD score (\>12) from deep sedation

Secondary Outcome Measures

Name	Time	Method
Propofol dose	Immediately after discontinuation of propofol infusion used for botulinum toxin injection	Amount of propofol to maintain deep sedation for botulinum toxin injection

Trial Locations

Locations (1)

Location Yeungnam University Hospita; 🇰🇷 Daegu, Korea, Republic of