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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group E (n=10) | Active Comparator | Patients with high Ig E levels |
|
| Group C (n=10) | Active Comparator | Patients with normal Ig E levels |
|
| Group M (n=10) | Active Comparator | Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | 4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurten Bakan, MD | Unraniye training and research hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulsah Karaoren | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25444114 | Background | 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. | |
| 25499571 | Result | 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. |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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