Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean Airway Pressures
研究概览
简要总结
Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single use device and the presence of a drain tube allows to separate the gastrointestinal and respiratory tracts. We planned to compare ventilation parameters and gastric distension scores of with LM-S vs ETT during laparoscopic gynecological surgery.
详细描述
This prospective, randomized and double-blind study received permission from "Dokuz Eylül University Medical Faculty Non-Interventional Research Ethics Committee" and after obtaining patients' informed consent, 100 patients with American society of anesthesiologists (ASA) classification group I-II, between 18-65 years, undergoing elective laparoscopic gynecological surgery were included.
Patients were divided into:
Group 1=>ETT (Endo tracheal group) (50 patients) Group 2=>LM-S (Laryngeal mask Supreme) (50 patients) Patients and surgeons performing the operation were not aware of which airway device was used. The patients in the groups were determined by block randomized methods.
Patients taken to the surgical room were given standard monitoring (non-invasive blood pressure measurements, electrocardiogram, and peripheral oxygen saturation measurements) before anesthesia induction. For preoperative sedation 0.02 mg/kg midazolam IV was administered.
Patients were preoxygenated with 6 L/min oxygen for 3 minutes through a face mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA classification group I-II
- •Between 18-65 years
- •Undergoing elective laparoscopic gynecological surgery
排除标准
- •Individuals with any neck and upper respiratory pathology
- •Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
- •Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
- •Obese patients (BMI >35)
- •Individuals with sore throat, dysphagia and dysphonia
- •Individuals with possibility or history of difficult airway
- •Operation time planned for more than 4 hours
研究组 & 干预措施
Group ETT (endo tracheal tube)
Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
干预措施: Endotracheal Tube (Device)
Group LM-S(Laryngeal mask supreme Group)
Experimental: Group LM-S Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.
干预措施: Laryngeal Mask Airway-Supreme (Device)
结局指标
主要结局
Mean Airway Pressures
时间窗: At first and last 10 minutes of pneumoperitoneum
The measure is the mean airway pressure (cmH2O): T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device
次要结局
- Throat Pain According to Visual Analogue Scale(postoperative 1st and 24th hours)
- Evaluation of Gastric Distention(Baseline)
研究者
Sule Ozbilgin
Anaesthesiology and Reanimation
Dokuz Eylul University