Clinical trial NCT03553446: 50% Effective Concentration of Sevoflurane for Immobility
Official title: 50% Effective Concentration of Sevoflurane for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetics, Inhalation
Keywords: Sevoflurane
Motion
Botulinum toxins
Cerebral palsy
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the incidence of immobility
timeFrame: during procedure (Botulinum injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
affiliation: Yeungnam University Hospital
name: Sung Mee Jung, M.D.,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim K, Lee E, Jung SM, Baek J. 50% effective concentration of sevoflurane for immobility in cerebral palsy children undergoing botulinum toxin injection. Medicine (Baltimore). 2022 Oct 21;101(42):e30928. doi: 10.1097/MD.0000000000030928.