50% Effective Concentration of Sevoflurane for Immobility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-29

Study Completion Date

2021-04-30

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.

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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.

Conditions

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Anesthetics, Inhalation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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children receiving sevoflurane

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

Group Type EXPERIMENTAL

children receiving sevoflurane

Intervention Type DRUG

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

Interventions

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children receiving sevoflurane

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

Intervention Type DRUG

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No