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WithdrawnNCT05505123Updated Feb 15, 2023

Sevoflurane and Propofol for Botulinum Toxin Injection

An interventional study of Sevoflurane and Propofol in Cerebral Palsy, sponsored by Yeungnam University College of Medicine. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Yeungnam University College of Medicine · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
3 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • cerebral palsy
  • sevoflurane
  • propofol
  • deep sedation
  • botulinum toxin
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

Browse Cerebral Palsy studies →

Lead sponsor

Yeungnam University College of Medicine is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with cerebral palsy (ages 3-11)

Exclusion criteria

Exclusion Criteria:

① Obestity : of 30 kg/m2 or more

  • Heart disease : 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    sevoflurane

    induction and maintenance with sevoflurane

    Drug: Sevoflurane

  • Experimental
    propofol

    induction and maintenance with propofol

    Drug: Propofol

Interventions

  • induction and maintenance with sevoflurane for deep sedation

    Also known as: sevoflurane group

  • induction and maintenance with propofol for deep sedation

    Also known as: propofol group

06

What researchers measure

Primary outcomes

  1. emergence time

    1 hour from discontinuation of drug administration to regain of consciousness

    Time frame: up to 1 hour

07

Study locations

1 site
  • Yeungnam University Medical Center
    Daegu, 42415, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05505123
Lead sponsor
Yeungnam University College of Medicine
Responsible party
Sung Mee Jung (professor, Yeungnam University College of Medicine) — Principal investigator
First posted
Aug 17, 2022
Start date
Aug 26, 2022
Primary completion
Dec 9, 2022
Completion
Dec 9, 2022
Last update
Feb 15, 2023

Study contacts

Sung Mee Jung, M.D.,PhD
principal investigator · Yeungnam University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Sevoflurane · Propofol

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