Anesthetics, InhalationNCT03553446
50% Effective Concentration of Sevoflurane for Immobility
A study testing children receiving sevoflurane in people with Anesthetics, Inhalation, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
Sevoflurane is as attractive inhalation agent fore deep sedation in children undergoing short invasive procedure because of lack of irritation to the respiratory tract, a pleasant odor and rapid clinical effect and recovery due to low blood gas partition coefficient. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anesthetics, Inhalation
- What is being tested?
- children receiving sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jul 2018to 30 Apr 2021
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-12 years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection
- American society of anesthesiologists Physical status 1-2
Who cannot join
- Body mass index > 30 kg/m2
- unstable heart disease
- Anticipated difficult airway history including congenital facial or airway anomaly
- Recent upper respiratory tract infection ( < 2 weeks)
- Gastroesophageal reflux
- Allergy history to sevoflurane, remifentanil or any drug used during procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
Sevoflurane is as attractive inhalation agent fore deep sedation in children undergoing short invasive procedure because of lack of irritation to the respiratory tract, a pleasant odor and rapid clinical effect and recovery due to low blood gas partition coefficient.
The aim of this study is to determine the optimum inspired concentration of sevoflurane required for immobility during botulinum toxin injection in spontaneously breathing children with cerebral palsy.
Read the detailed description
All anesthetics were administered by a single experienced anesthesiologist. Anesthetic induction was performed progressively with inhaled 1-8% sevoflurane, if the patient was cooperative, otherwise directly to the 8%, and subsequent maintenance 2% in oxygen at 5 L /min. A face mask was connected to a Mapleson C circuit for it. Patients breathed spontaneously, unaided, via a pediatric face mask. A failure was defined as the patient continued to move after following the study protocol for sevoflurane inhalation. Insufficient sedation was treated with increments of 0.5% concentration to achieve the desired effect, ie, maintenance of immobility during botulinum toxin injection. The sevoflurane concentration in the next patient would be adjusted depending on the success or failure for immobility at given sevoflurane concentration ( if successful, 0.5% lower concentration, if failed, 0.5% higher concentration).
The child was recovered from sevoflurane sedation at the end of botulinum toxin injection and transferred to post-anesthetic care unit.
- Conditions
- Anesthetics, Inhalation
- Being tested
- children receiving sevoflurane
- Keywords
- Sevoflurane, Motion, Botulinum toxins, Cerebral palsy
- Medical subject headings
- Respiratory Aspiration, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
children receiving sevofluraneDrug
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
| Study group | Role | What they receive |
|---|---|---|
| children receiving sevoflurane | Experimental | Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method Receives: Drug: children receiving sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of immobility
cerebral palsy child who maintains immobility during botulinum toxin injection
Measured: during procedure (Botulinum injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start29 Jul 2018
- Primary completion26 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthetics, InhalationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT03553446
- Sponsor's protocol ID
- YUMC-2018-04-023
- Status last verified
- Jun 2022
- First submitted
- 8 May 2018
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim K, Lee E, Jung SM, Baek J. 50% effective concentration of sevoflurane for immobility in cerebral palsy children undergoing botulinum toxin injection. Medicine (Baltimore). 2022 Oct 21;101(42):e30928. doi: 10.1097/MD.0000000000030928.
PubMed 36281165
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
- ClinicalTrials.gov ID
- NCT03553446
- Acronym / sponsor ID
- YUMC-2018-04-023
- Conditions
- Anesthetics, Inhalation
- Keywords
- Sevoflurane, Motion, Botulinum toxins, Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 29 Jul 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 12 Jun 2018 (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.
Sevoflurane is as attractive inhalation agent fore deep sedation in children undergoing short invasive procedure because of lack of irritation to the respiratory tract, a pleasant odor and rapid clinical effect and recovery due to low blood gas partition coefficient.
The aim of this study is to determine the optimum inspired concentration of sevoflurane required for immobility during botulinum toxin injection in spontaneously breathing children with cerebral palsy.
Detailed description
All anesthetics were administered by a single experienced anesthesiologist. Anesthetic induction was performed progressively with inhaled 1-8% sevoflurane, if the patient was cooperative, otherwise directly to the 8%, and subsequent maintenance 2% in oxygen at 5 L /min. A face mask was connected to a Mapleson C circuit for it. Patients breathed spontaneously, unaided, via a pediatric face mask. A failure was defined as the patient continued to move after following the study protocol for sevoflurane inhalation. Insufficient sedation was treated with increments of 0.5% concentration to achieve the desired effect, ie, maintenance of immobility during botulinum toxin injection. The sevoflurane concentration in the next patient would be adjusted depending on the success or failure for immobility at given sevoflurane concentration ( if successful, 0.5% lower concentration, if failed, 0.5% higher concentration).
The child was recovered from sevoflurane sedation at the end of botulinum toxin injection and transferred to post-anesthetic care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children receiving sevoflurane | Experimental | Drug: children receiving sevofluraneChildren receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3-12 years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection
- American society of anesthesiologists Physical status 1-2
Key exclusion criteria (6 listed)
- Body mass index > 30 kg/m2
- unstable heart disease
- Anticipated difficult airway history including congenital facial or airway anomaly
- Recent upper respiratory tract infection ( < 2 weeks)
- Gastroesophageal reflux
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 |
|---|---|---|
| children receiving sevofluraneChildren receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method | Drug | children receiving sevoflurane |
Primary outcome
the incidence of immobility
Time frame: during procedure (Botulinum injection)
cerebral palsy child who maintains immobility during botulinum toxin injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Derived from this study: PubMed 36281165Kim K, Lee E, Jung SM, Baek J. 50% effective concentration of sevoflurane for immobility in cerebral palsy children undergoing botulinum toxin injection. Medicine (Baltimore). 2022 Oct 21;101(42):e30928. doi: 10.1097/MD.0000000000030928.
Related trials for Anesthetics, Inhalation
Not yet recruiting
Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children
Anaesthetic Induction, Respiratory Complications of Care
Not yet recruitingPhase 2
The Effect of Inhalation Aromatherapy on Intraoperative Fear in Patients Undergoing Lower Blepharoplasty Under Local Anesthesia: A Randomized Controlled Trial
Lower Eyelid Bags
Not yet recruitingObservational study
Endotracheal Tube Intolerance and Respiratory Airflow Perception
Coughing Responses at Tracheal Extubation, Breathing Patterns
Recruiting
Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery
Opioid Use, Bariatric Surgery Candidate
RecruitingPhase 3
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
Intensive Care Units, Pediatric, Anesthetics, Inhalation
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 children receiving sevoflurane in people with Anesthetics, Inhalation, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the incidence of immobility (time frame: during procedure (Botulinum injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553446, which also lists 1 linked publication.
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 23 Jun 2022.