A randomised clinical trial comparing the effectiveness of Ambu® AuraGain™ laryngeal mask airway with LMA ProSeal ™ in patients undergoing laparoscopic surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure and mucosal pressure
研究概览
简要总结
Our study has been designed to compare Ambu®AuraGainâ„¢ laryngeal mask airway with LMAProSealâ„¢ in terms of whichwould provide a high oropharyngeal leak pressure with less pharyngeal mucosalpressure. LMA ProSealâ„¢ is a re-usable second generation SAD which formsan effective “First Seal ™†with the oropharynx (oropharyngeal seal) and aninnovative “Second Sealâ„¢â€with the upper oesophageal sphincter (oesophagealseal). Ambu® AuraGainâ„¢ is a newsecond generation SAD, satisfying 3 fundamental airway management needs byintegrating gastric access and intubation capability in an anatomically curvedsingle use device that facilitates rapid establishment of a safe airway. Primary outcome isOropharyngeal leak pressure and mucosal pressure. Secondaryoutcomes are: Timerequired for insertion, numberof insertion attempts ,ease of insertion, hemodynamic responseassociated with insertion Size of the laryngeal mask airway is selected basedon the body weight of the patient. IV Fentanyl 2 microgram / kilogram of bodyweight (kg BW) is given. After 2 minutes, induction with propofol 2 to 2.5mg/kg BW IV is done. After check-ventilation, muscle relaxant vecuronium 0.1mg/kgIV is administered. Patients are ventilated for 3 minutes with face mask tilladequate jaw relaxation is achieved. Before inserting the laryngeal maskairway, irrespective of the group allocated, cuff of the laryngeal mask airway isinflated with the maximum permissible air recommended by the manufacturer and the cuff pressure noted with a cuffpressure manometer and is noted as Pexvivo. The laryngeal mask airway is fully deflated and lubricated with awater-soluble gel. After adequate depth of anesthesia and muscle relaxation isachieved, the device ( LMAProSealâ„¢or Ambu® AuraGainâ„¢) is inserted by an experienced anesthesiologist Thefollowing parameters are recorded :
Time taken forinsertion
Number of insertion attempts
Ease ofinsertion.
In vivo cuff pressure
Hemodynamic parameters: Heart rate and blood pressureare recorded at 1 minute intervals during the insertion and until 5 minutesafter
Oropharyngeal leakpressure is noted immediately after insertion of the laryngeal mask airway and after creation of pneumoperitoneum , at15min intervals for 1 hour
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who are undergoing elective laparoscopic surgeries 2.Age:18-65years 3.ASA physical status I and II 4.Those willing to participate.
排除标准
- •1.Patient refusal 2.ASA physical status III and IV 3.Obesity BMI>30 kilograms per meter square 4.Pregnancy 5.High risk of pulmonary aspiration , inadequate fasting, gastro-esophageal reflux disease (GERD) •Restricted mouth opening.
结局指标
主要结局
Oropharyngeal leak pressure and mucosal pressure
时间窗: Oropharyngeal leak pressure and mucosal pressure in cm of water at insertion,after pneumoperitonium,at 30,60,90,120 minutes
次要结局
- Time required for insertion(seconds)
- Number of insertion attempts(1,2,3)