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Clinical Trials/NCT03553446
NCT03553446
Completed
Not Applicable

50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection

Yeungnam University College of Medicine1 site in 1 country23 target enrollmentJuly 29, 2018

Overview

Phase
Not Applicable
Intervention
children receiving sevoflurane
Conditions
Anesthetics, Inhalation
Sponsor
Yeungnam University College of Medicine
Enrollment
23
Locations
1
Primary Endpoint
the incidence of immobility
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 29, 2018
End Date
April 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sung Mee Jung

Professor

Yeungnam University College of Medicine

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

Arms & Interventions

children receiving sevoflurane

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

Intervention: children receiving sevoflurane

Outcomes

Primary Outcomes

the incidence of immobility

Time Frame: during procedure (Botulinum injection)

cerebral palsy child who maintains immobility during botulinum toxin injection

Study Sites (1)

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