Skip to content

Preoperative Use of Montelukast Sodium

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494466
Enrollment
30
Registered
2015-07-10
Start date
2014-05-31
Completion date
2015-06-30
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Reactivity

Keywords

Airway Resistance, montelukast sodium, laryngeal mask airway

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.

Interventions

DRUGmontelukast sodium

4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

Sponsors

Umraniye Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Number of Participants with bronchospasm as a Measure of airway reactivityduring the operation
Number of Participants with laryngospasm as a Measure of airway reactivityduring the operation
Number of Participants with apneaduring the operation

Secondary

MeasureTime frameDescription
amount of applied steroidsduring the operationsteroids can prevent airway reactivity symptoms
peak airway pressures as a measurement of airway reactivityduring the operation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026