Preoperative Use of Montelukast Sodium

Umraniye Education and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Airway Reactivity

Treatments: Drug: montelukast sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02494466

GK6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Group E (n=10)

Active Comparator group

Description:

Patients with high Ig E levels

Treatment:

Drug: montelukast sodium

Group C (n=10)

Active Comparator group

Description:

Patients with normal Ig E levels

Treatment:

Drug: montelukast sodium

Group M (n=10)

Active Comparator group

Description:

Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE

Treatment:

Drug: montelukast sodium