Sevoflurane and Propofol for Botulinum Toxin Injection
Primary Purpose
Cerebral Palsy
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, sevoflurane, propofol, deep sedation, botulinum toxin
Eligibility Criteria
Inclusion Criteria:
- Children with cerebral palsy (ages 3-11)
Exclusion Criteria:
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
Sites / Locations
- Yeungnam University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
sevoflurane
propofol
Arm Description
induction and maintenance with sevoflurane
induction and maintenance with propofol
Outcomes
Primary Outcome Measures
emergence time
1 hour from discontinuation of drug administration to regain of consciousness
Secondary Outcome Measures
Full Information
NCT ID
NCT05505123
First Posted
August 12, 2022
Last Updated
February 13, 2023
Sponsor
Yeungnam University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05505123
Brief Title
Sevoflurane and Propofol for Botulinum Toxin Injection
Official Title
Comparison of Sevoflurane and Propofol for Botulinum Toxin Injection in Cerebral Palsy Children: A Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Cerebral palsy is the most common cause of spastic movement disorders in children. Because botulinum toxin blocks nerve transmission and relieves excessive muscle contraction, it is widely used in the treatment of spastic movement disorders in children with cerebral palsy. Botulinum toxin should be injected into the motor end plate of the neuromuscular junction to increase the therapeutic effect and reduce the immune resistance, and side effects. However, it is difficult for pediatric patients to maintain an immobile posture due to fear of the procedure and injection pain. Moreover, even if a patient with cerebral palsy has the will to maintain an immobile posture through preoperative interviews and prior education, it is not easy to control body movements by themselves due to stiffness.
Botulinum toxin injection is a simple procedure, so the procedure time is very short, usually 5-10 minutes. Therefore, it was performed while maintaining spontaneous breathing without an invasive airway maintenance device (e.g., using a neuromuscular blocker and inserting an endotracheal tube or superior laryngeal airway maintainer), unless difficult airway management is anticipated. It is important to provide a deep sedation during the procedure and then to allow for a rapid recovery of consciousness when the drug is stopped after the procedure. Therefore, in clinical practice, intravenous anesthetic such as propofol or inhaled anesthetic such as sevoflurane, both are short-acting drugs, are administered to induce and maintain deep sedation.
When using propofol, the drug can be administered through the intravenous route secured in advance in all patients before sedation or anesthesia, so sedation can be quickly induced without patient cooperation. It has the advantage of being able to restore consciousness without emergence delirium during awakening. However, when propofol is administered intravenously, pain may occur, respiration and cardiovascular depression may be compromised. In addition, because pharmacokinetic model equipment that can monitor the effect site (brain) drug concentration in real time is not universally used in children, the propofol dosage is often adjusted according to the patient's response which leads to a risk of being administered excessively or inadequately.
When using sevoflurane, it can induce sedation without injection pain. When the drug administration is stopped after the procedure, the drug can be eliminated through the patient's exhalation, which leads to rapid recovery of consciousness. Through anesthetic circuit, the concentration of the drug administered to and removed from the patient can be measured in real time, so it is easy to adjust the drug administration dose. Sevoflurane has the advantage of having some muscle relaxation effect in contrast to propofol. However, since sedation is induced only when the drug is inhaled through spontaneous respiration, patient cooperation is required. The frequency of occurrence of delirium and nausea/vomiting during emergence of sevoflurane is higher than that of propofol.
However, to date, no studies directly comparing the clinical aspects (safety, effectiveness, recovery, adverse events) and satisfaction with sedation of propofol and sevoflurane, for deep sedation during botulinum toxin injection in children with cerebral palsy, have not been reported. Therefore, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, sevoflurane, propofol, deep sedation, botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
induction and maintenance with sevoflurane
Arm Title
propofol
Arm Type
Experimental
Arm Description
induction and maintenance with propofol
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
sevoflurane group
Intervention Description
induction and maintenance with sevoflurane for deep sedation
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
propofol group
Intervention Description
induction and maintenance with propofol for deep sedation
Primary Outcome Measure Information:
Title
emergence time
Description
1 hour from discontinuation of drug administration to regain of consciousness
Time Frame
up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with cerebral palsy (ages 3-11)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Mee Jung, M.D.,PhD
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sevoflurane and Propofol for Botulinum Toxin Injection
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