Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-04-18 @ 8:43 AM
Study NCT ID:
NCT02494466
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2015-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Use of Montelukast Sodium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-07', 'studyFirstSubmitDate': '2015-05-05', 'studyFirstSubmitQcDate': '2015-07-07', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with bronchospasm as a Measure of airway reactivity', 'timeFrame': 'during the operation'}, {'measure': 'Number of Participants with laryngospasm as a Measure of airway reactivity', 'timeFrame': 'during the operation'}, {'measure': 'Number of Participants with apnea', 'timeFrame': 'during the operation'}], 'secondaryOutcomes': [{'measure': 'amount of applied steroids', 'timeFrame': 'during the operation', 'description': 'steroids can prevent airway reactivity symptoms'}, {'measure': 'peak airway pressures as a measurement of airway reactivity', 'timeFrame': 'during the operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Airway Resistance', 'montelukast sodium', 'laryngeal mask airway'], 'conditions': ['Airway Reactivity']}, 'referencesModule': {'references': [{'pmid': '25444114', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25499571', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children.\n\nMontelukast 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.', 'detailedDescription': '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.\n\nPatients 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.\n\nWith 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing inguinal hernia surgery\n\nExclusion Criteria:\n\n* If receiving asthma treatment,\n* If they had URTI in the last week and\n* If LMA could not be placed at a single attempt.'}, 'identificationModule': {'nctId': 'NCT02494466', 'briefTitle': 'Preoperative Use of Montelukast Sodium', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium', 'orgStudyIdInfo': {'id': 'GK6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group E (n=10)', 'description': 'Patients with high Ig E levels', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C (n=10)', 'description': 'Patients with normal Ig E levels', 'interventionNames': ['Drug: montelukast sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group M (n=10)', 'description': 'Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE', 'interventionNames': ['Drug: montelukast sodium']}], 'interventions': [{'name': 'montelukast sodium', 'type': 'DRUG', 'description': '4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.', 'armGroupLabels': ['Group C (n=10)', 'Group E (n=10)', 'Group M (n=10)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gulsah Karaoren', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nurten Bakan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unraniye training and research hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gulsah Karaoren', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}