50% Effective Concentration of Sevoflurane for Immobility

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthetics, Inhalation

Intervention / Treatment
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* Drug: children receiving sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children receiving sevoflurane<br>Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method | Drug: children receiving sevoflurane<br>* Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of immobility | cerebral palsy child who maintains immobility during botulinum toxin injection | during procedure (Botulinum injection) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, Motion, Botulinum toxins, Cerebral palsy