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.
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.
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 group | Role | What they receive |
|---|---|---|
| sevoflurane | Experimental | induction and maintenance with sevoflurane Receives: Drug: Sevoflurane |
| propofol | Experimental | induction and maintenance with propofol Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Aug 2022
- Study start26 Aug 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Mee Jung, Yeungnam University College of Medicine
- Investigators
- Sung Mee Jung, M.D.,PhD, Principal investigator, Yeungnam University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Propofol for Botulinum Toxin Injection in Cerebral Palsy Children: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT05505123
- Acronym / sponsor ID
- YUMC 2022-07-038-001
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, sevoflurane, propofol, deep sedation, botulinum toxin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Experimental | Drug: Sevofluraneinduction and maintenance with sevoflurane |
| propofol | Experimental | Drug: Propofolinduction and maintenance with propofol |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with cerebral palsy (ages 3-11)
Key exclusion criteria (4 listed)
- ① Obestity : Body Mass Index of 30 kg/m2 or more
- Heart disease : NYHA class >2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: sevoflurane groupinduction and maintenance with sevoflurane for deep sedation | Drug | sevoflurane |
| PropofolAlso: propofol groupinduction and maintenance with propofol for deep sedation | Drug | propofol |
Primary outcome
emergence time
Time frame: up to 1 hour
1 hour from discontinuation of drug administration to regain of consciousness
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Mee Jung, M.D.,PhD principal investigator
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
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.