Preoperative Use of Montelukast Sodium

Study Overview
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Brief Summary
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Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children. Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.

Detailed Description
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The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8 years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma treatment, if they had upper respiratory tract infection in the last week and if the laryngeal mask airway (LMA) could not be placed at a single attempt. Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE), Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral Montelukast Sodium, 10 days before surgery because of high IgE. With spontaneous breathing after anaesthesia induction, a classic LMA will be placed. Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC) sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP) will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for steroids will be noted.

Official Title
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The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium

Conditions
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Airway Reactivity

Intervention / Treatment
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* Drug: montelukast sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing inguinal hernia surgery Exclusion Criteria: If receiving asthma treatment, If they had URTI in the last week and If LMA could not be placed at a single attempt.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E (n=10)<br>Patients with high Ig E levels | Drug: montelukast sodium<br>* 4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.<br>|
| Active Comparator: Group C (n=10)<br>Patients with normal Ig E levels | Drug: montelukast sodium<br>* 4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.<br>|
| Active Comparator: Group M (n=10)<br>Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE | Drug: montelukast sodium<br>* 4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with bronchospasm as a Measure of airway reactivity |  | during the operation | 
| Number of Participants with laryngospasm as a Measure of airway reactivity |  | during the operation | 
| Number of Participants with apnea |  | during the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of applied steroids | steroids can prevent airway reactivity symptoms | during the operation | 
| peak airway pressures as a measurement of airway reactivity |  | during the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Resistance, montelukast sodium, laryngeal mask airway