Comparison between two supraglottic airway devices i-gel vs Laryngeal mask airway-unique on easiness of insertion during general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of insertion
研究概览
简要总结
Randomized controlled trial to be conducted at the OTs of Government medical college Thiruvananthapuram , comparing the easiness of insertion of two supraglottic airway devices - i-gel and LMA-unique in patients who undergo surgery under general anaesthesia. ASA 1 & 2 patients in the age group 20 - 60 years selected after a thorough pre anaesthetic assessment and informed consent will be randomized into two groups. General anaesthesia will be performed after all the necessary preparations , intravenous access and monitors. Premedication with midazolam , fentanyl , metoclopramide and glycopyrrolate ( in the premedicant doses ) is followed by preoxygenation and induction with propofol . Muscle relaxation is achieved with a single dose of 2mg/kg succinyl choline . At an adequate depth , 1st group patients’ airway is secured with an i-gel while the 2nd group receives LMA-unique (according to the manufacturer recommended size selection and instructions). Ventilation is checked to be optimal. maintenance is with nitrous oxide - oxygen in ratio 4:2 and infusion of propofol. Time taken to insert device , insertion and reposition attempts , sealing pressures , leak volumes are noted and hemodynamic parameters are monitored. At the end of the surgery , the device is removed when the patients regain consciousness and can respond to verbal commands. Airway complications are noted and postoperative complications are sought for and managed.
References
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Brimacombe , Keller , Morris , Mecklem . Comparison of disposable with reusable LMA in paralyzed adult patients . Anaesthesia analgesia 1998; 87:921-4
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Uppal , Gangaiah , Fletcher , Kinsella . Randomized crossover comparison between i-gel and LMA-unique in anaesthetized paralysed patients. BJA 2009;103(6):882-885
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Helmy , Atef , El-Taher , Henidak. Comparative study between i-gel and classic LMA in anaesthetised spontaneously ventilated patients. Saudi journal of anaesthesia 2010; volume 4,issue 3:131-136
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy patient without organic, biochemical, or psychiatric disease ASA
- •A patient with mild systemic disease, e.g., mild asthma or well-controlled hypertension. No significant impact on daily activity. Unlikely to have an impact on anesthesia and surgery.
排除标准
- •ASA 3- Significant or severe systemic disease that limits normal activity, e.g., renal failure on dialysis or class 2 congestive heart failure.
- •Significant impact on daily activity.
- •Probable impact on anesthesia and surgery ASA 4-Severe disease that is a constant threat to life or requires intensive therapy, e.g., acute myocardial infarction, respiratory failure requiring mechanical ventilation.
- •Major impact on anesthesia and surgery ASA 5-Moribund patient who is equally likely to die in the next 24 hours with or without surgery ASA 6-Brain-dead organ donor Duration of surgery more than 2 hours Emergency surgery Surgery in positions other than supine Pathology of neck or upper repiratory tract Potential difficult intubation Mouth opening less than 2.5 cms Pregnant women BMI more than 35 kg/m2 Patients with reported hypersensitivity for one or more medications and latex Increased risk of aspiration ( hiatus hernia , gastro esophageal reflux , full stomach ).
结局指标
主要结局
Duration of insertion
时间窗: Time from picking up the device to first successful breath made by manual ventilation
次要结局
- Reposition attempts(Manipulations allowed: gentle pushing or pulling of the device, chin lift, jaw thrust, head extension, or neck flexion.)
- Leak volumes(The difference between inspired tidal volume (ITV) and expired tidal volume (ETV))
- Number of insertion attempts(A failed attempt is defined as removal of the device from the mouth before re-insertion.)
- Hemodynamic effects(Pulse Rate , Blood Pressure (systolic , diastolic & mean) , Oxygen saturation are monitored and recorded.)
- Sealing pressure (airway leak pressure)(Measuring the minimal airway pressure at which an audible gas leak occurred using a stethoscope placed just lateral to thyroid cartilage.)
- Perioperative Complications(Bronchospasm ,Laryngospasm and coughing , trauma , postoperative sore throat (constant pain, independent of swallowing), dysphagia (difficulty or pain with swallowing), dysphonia (difficulty or pain with speaking))