Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05505123 |
| Other study ID # |
YUMC 2022-07-038-001 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 26, 2022 |
| Est. completion date |
December 9, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Yeungnam University College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 spastic cerebral palsy receiving botulinum toxin
injection.
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.
