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Completed

NCT Number: NCT02494466

Preoperative Use of Montelukast Sodium

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.

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Key information

Conditions

Airway Reactivity

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gulsah Karaoren

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

montelukast sodium

Drug

4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

Primary outcomes

  1. Number of Participants with bronchospasm as a Measure of airway reactivity

    Time frame: during the operation

  2. Number of Participants with laryngospasm as a Measure of airway reactivity

    Time frame: during the operation

  3. Number of Participants with apnea

    Time frame: during the operation

Secondary outcomes

  1. amount of applied steroids

    Time frame: during the operation

    steroids can prevent airway reactivity symptoms

  2. peak airway pressures as a measurement of airway reactivity

    Time frame: during the operation

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2015
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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