The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with apnea
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing inguinal hernia surgery
排除标准
- •If receiving asthma treatment,
- •If they had URTI in the last week and
- •If LMA could not be placed at a single attempt.
研究组 & 干预措施
Group E (n=10)
Patients with high Ig E levels
干预措施: montelukast sodium (Drug)
Group C (n=10)
Patients with normal Ig E levels
干预措施: montelukast sodium (Drug)
Group M (n=10)
Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE
干预措施: montelukast sodium (Drug)
结局指标
主要结局
Number of Participants with apnea
时间窗: during the operation
Number of Participants with bronchospasm as a Measure of airway reactivity
时间窗: during the operation
Number of Participants with laryngospasm as a Measure of airway reactivity
时间窗: during the operation
次要结局
- amount of applied steroids(during the operation)
- peak airway pressures as a measurement of airway reactivity(during the operation)
研究者
Gulsah Karaoren
MD
Umraniye Education and Research Hospital