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50% Effective Concentration of Sevoflurane for Immobility

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03553446
Enrollment
23
Registered
2018-06-12
Start date
2018-07-29
Completion date
2021-04-30
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Inhalation

Keywords

Sevoflurane, Motion, Botulinum toxins, Cerebral palsy

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.

Interventions

DRUGchildren receiving sevoflurane

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

Sponsors

Yeungnam University College of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of immobilityduring procedure (Botulinum injection)cerebral palsy child who maintains immobility during botulinum toxin injection

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026