NCT02494466

Preoperative Use of Montelukast Sodium

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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.

Conditions

• Airway Reactivity

Interventions

Type	Name	Description
DRUG	montelukast sodium	4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-07-10
• Last updated: 2015-07-10

Locations

1 site across 1 country: Turkey (Türkiye)