Preoperative Use of Montelukast Sodium

Phase 4

Completed

• Conditions: Airway Reactivity
• Interventions: Drug: montelukast sodium

• Registration Number: NCT02494466
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-05-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-07
• Last Update Submitted: 2015-07-07
• Study First Posted: 2015-07-10
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group C (n=10)	montelukast sodium	Patients with normal Ig E levels
Group M (n=10)	montelukast sodium	Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE
Group E (n=10)	montelukast sodium	Patients with high Ig E levels

Primary Outcome Measures

Name	Time	Method
Number of Participants with apnea	during the operation
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

Secondary Outcome Measures

Name	Time	Method
amount of applied steroids	during the operation	steroids can prevent airway reactivity symptoms
peak airway pressures as a measurement of airway reactivity	during the operation

Trial Locations

Locations (1)

Gulsah Karaoren; 🇹🇷 Istanbul, Turkey