Preoperative Use of Montelukast Sodium

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Reactivity
• Intervention / Treatment: Drug: montelukast sodium

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • gulsah Karaoren

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Publications and helpful links

General Publications

• Casares-Alonso I, Cano-Garcinuno A, Blanco-Quiros A, Perez-Garcia I. Anti-asthmatic prescription variability in children according to age. Allergol Immunopathol (Madr). 2015 Jul-Aug;43(4):383-91. doi: 10.1016/j.aller.2014.05.010. Epub 2014 Oct 23.
• Bush A. Montelukast in paediatric asthma: where we are now and what still needs to be done? Paediatr Respir Rev. 2015 Mar;16(2):97-100. doi: 10.1016/j.prrv.2014.10.007. Epub 2014 Dec 12.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 5, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: montelukast sodium; laryngeal mask airway; Airway Resistance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: GK6