Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2014-05-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Group E (n=10)
Patients with high Ig E levels
montelukast sodium
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Group C (n=10)
Patients with normal Ig E levels
montelukast sodium
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Group M (n=10)
Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE
montelukast sodium
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Interventions
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montelukast sodium
4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* If they had URTI in the last week and
* If LMA could not be placed at a single attempt.
4 Years
8 Years
ALL
Yes
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Responsible Party
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Gulsah Karaoren
MD
Principal Investigators
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Nurten Bakan, MD
Role: STUDY_CHAIR
Unraniye training and research hospital
Locations
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Gulsah Karaoren
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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GK6
Identifier Type: -
Identifier Source: org_study_id
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