50% Effective Concentration of Sevoflurane for Immobility
1 other identifier
interventional
23
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
July 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJune 23, 2022
June 1, 2022
2.7 years
May 8, 2018
June 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of immobility
cerebral palsy child who maintains immobility during botulinum toxin injection
during procedure (Botulinum injection)
Study Arms (1)
children receiving sevoflurane
EXPERIMENTALChildren receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Interventions
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Eligibility Criteria
You may qualify if:
- years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection
- American society of anesthesiologists Physical status 1-2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yeungnam University Hospital
Daegu, 42415, South Korea
Related Publications (1)
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.
PMID: 36281165DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung Mee Jung, M.D.,PhD.
Yeungnam University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 8, 2018
First Posted
June 12, 2018
Study Start
July 29, 2018
Primary Completion
March 26, 2021
Study Completion
April 30, 2021
Last Updated
June 23, 2022
Record last verified: 2022-06