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Cerebral PalsyNCT05505123

Sevoflurane and Propofol for Botulinum Toxin Injection

A study testing Sevoflurane and Propofol in people with Cerebral Palsy, run by Yeungnam University College of Medicine at 1 site in South Korea.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 11 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Sevoflurane and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteSouth Korea
Study dates
26 Aug 2022to 9 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children with cerebral palsy (ages 3-11)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Yeungnam University Medical Center

    Daegu, 42415

Other trials in South Korea

About this study

Official title: Comparison of Sevoflurane and Propofol for Botulinum Toxin Injection in Cerebral Palsy Children: A Prospective, Randomized Trial

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.

Conditions
Cerebral Palsy
Being tested
Sevoflurane, Propofol
Keywords
cerebral palsy, sevoflurane, propofol, deep sedation, botulinum toxin
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    Also called sevoflurane group

    induction and maintenance with sevoflurane for deep sedation

  • PropofolDrug

    Also called propofol group

    induction and maintenance with propofol for deep sedation

Study groups in NCT05505123
Study groupRoleWhat they receive
sevofluraneExperimentalinduction and maintenance with sevoflurane
Receives: Drug: Sevoflurane
propofolExperimentalinduction and maintenance with propofol
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. emergence time

    1 hour from discontinuation of drug administration to regain of consciousness

    Measured: up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start26 Aug 2022
  3. Primary completion9 Dec 2022
  4. Study completion9 Dec 2022

Why it stopped: No participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505123
Sponsor's protocol ID
YUMC 2022-07-038-001
Status last verified
Feb 2023
First submitted
12 Aug 2022
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sevoflurane and Propofol in people with Cerebral Palsy, run by Yeungnam University College of Medicine at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

emergence time (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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