Clinical trial NCT02494466: Preoperative Use of Montelukast Sodium
Official title: The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Airway Reactivity
Keywords: Airway Resistance
montelukast sodium
laryngeal mask airway
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: amount of applied steroids
timeFrame: during the operation
measure: peak airway pressures as a measurement of airway reactivity
timeFrame: during the operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gulsah Karaoren
Study officials:
affiliation: Unraniye training and research hospital
name: Nurten Bakan, MD
role: STUDY_CHAIR
References:
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.
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.