50% Effective Concentration of Sevoflurane for Immobility

Anesthetics, Inhalation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553446
• Other study ID #: YUMC-2018-04-023
• Status: Completed
• Phase: N/A
• Start date: July 29, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2022
• Source: Yeungnam University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 30, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetics, Inhalation
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of immobility	cerebral palsy child who maintains immobility during botulinum toxin injection	during procedure (Botulinum injection)