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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03553446
Other study ID # YUMC-2018-04-023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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