50% Effective Concentration of Sevoflurane for Immobility

Not Applicable

Completed

• Conditions: Anesthetics, Inhalation
• Interventions: Drug: children receiving sevoflurane

• Registration Number: NCT03553446
• Lead Sponsor: Yeungnam University College of Medicine

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.

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Study Start: 2018-07-29
• Primary Completion: 2021-03-26
• Study Completion: 2021-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the incidence of immobility	during procedure (Botulinum injection)	cerebral palsy child who maintains immobility during botulinum toxin injection

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of