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50% Effective Concentration of Sevoflurane for Immobility

Primary Purpose

Anesthetics, Inhalation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
children receiving sevoflurane
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthetics, Inhalation focused on measuring Sevoflurane, Motion, Botulinum toxins, Cerebral palsy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 3-12 years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection
  • American society of anesthesiologists Physical status 1-2

Exclusion Criteria:

  • 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

Sites / Locations

  • Yeungnam University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

children receiving sevoflurane

Arm Description

Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method

Outcomes

Primary Outcome Measures

the incidence of immobility
cerebral palsy child who maintains immobility during botulinum toxin injection

Secondary Outcome Measures

Full Information

First Posted
May 8, 2018
Last Updated
June 16, 2022
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03553446
Brief Title
50% Effective Concentration of Sevoflurane for Immobility
Official Title
50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 29, 2018 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthetics, Inhalation
Keywords
Sevoflurane, Motion, Botulinum toxins, Cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
children receiving sevoflurane
Arm Type
Experimental
Arm Description
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Intervention Type
Drug
Intervention Name(s)
children receiving sevoflurane
Intervention Description
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Primary Outcome Measure Information:
Title
the incidence of immobility
Description
cerebral palsy child who maintains immobility during botulinum toxin injection
Time Frame
during procedure (Botulinum injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3-12 years old children with cerebral palsy receiving sevoflurane inhalation for botulinum toxin injection American society of anesthesiologists Physical status 1-2 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Mee Jung, M.D.,PhD.
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36281165
Citation
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.
Results Reference
derived

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50% Effective Concentration of Sevoflurane for Immobility

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