Sevoflurane and Propofol for Botulinum Toxin Injection

NCT05505123 | Withdrawn DMC

• 1 other identifier: YUMC 2022-07-038-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators would like to compare clinical features (onset, duration, emergence time), efficacy of deep sedation (successful completion of procedure), safety (adverse events) and caregiver's satisfaction for sedation when used propofol and sevoluflurane for deep sedation in 3-11 year old pediatric patients with spastic cerebral palsy receiving botulinum toxin injection.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; sevoflurane; propofol; deep sedation; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• emergence time

  1 hour from discontinuation of drug administration to regain of consciousness

  up to 1 hour

Study Arms (2)

sevoflurane

EXPERIMENTAL

induction and maintenance with sevoflurane

Drug: Sevoflurane

propofol

EXPERIMENTAL

induction and maintenance with propofol

Drug: Propofol

Interventions

Sevoflurane DRUG

induction and maintenance with sevoflurane for deep sedation

Also known as: sevoflurane group

sevoflurane

Propofol DRUG

induction and maintenance with propofol for deep sedation

Also known as: propofol group

propofol

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with cerebral palsy (ages 3-11)

You may not qualify if:

• ① Obestity : Body Mass Index of 30 kg/m2 or more
• Heart disease : NYHA class \>2
• Laryngomalacia
• Acute upper respiratory disease or asthma ⑤ Gastroesophageal reflux disease ⑥ Allergy to general anesthetics and drugs planned for use in this study

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (1)

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Sung Mee Jung, M.D.,PhD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: August 26, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)