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Sevoflurane Concentration for Immobility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03553446
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : January 25, 2019
Information provided by (Responsible Party):
Sung Mee Jung, Yeungnam University College of Medicine

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.

Condition or disease Intervention/treatment Phase
Anesthetics, Inhalation Drug: children receiving sevoflurane Not Applicable

Detailed Description:

All anesthetics were administered by a single experienced anesthesiologist. Before administration of sevoflurane, remifentanil infusion was started at a rate of 0.05 μg/kg/min without initial bolus. Five minutes after the start of the remifentanil infusion, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Optimum Sevoflurane Concentration for Immobility in Cerebral Palsy Children Undergoing Botulinum Toxin Injection
Actual Study Start Date : July 29, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Experimental: children receiving sevoflurane
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
Drug: children receiving sevoflurane
Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method

Primary Outcome Measures :
  1. the incidence of immobility [ Time Frame: during procedure (Botulinum injection) ]
    cerebral palsy child who maintains immobility during botulinum toxin injection

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03553446

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Contact: Sung Mee Jung, M.D., PhD. +82-53-620-3368

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Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Contact: Kyunghee Lee, M.D.,PhD.         
Sponsors and Collaborators
Yeungnam University College of Medicine
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Principal Investigator: Sung Mee Jung, M.D.,PhD. Yeungnam University Hospital

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Responsible Party: Sung Mee Jung, Professor, Yeungnam University College of Medicine Identifier: NCT03553446     History of Changes
Other Study ID Numbers: YUMC-2018-04-023
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sung Mee Jung, Yeungnam University College of Medicine:
Botulinum toxins
Cerebral palsy
Additional relevant MeSH terms:
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Respiratory Aspiration
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants