Patients will be assessed and scheduled for routine major surgery
10min before surgery Pre-medication will be given with Inj.Midazolam 0.02mg/kg IV , Inj.Fentanyl 1.5 µg/kg I.V Induction is done with Inj. Propofol - 2mg/kg IV mg/kg, and Inj. Atracurium - 0.5 mg/kg to facilitate SupraGlottic Airway Device(SAD) insertion. SAD insertion will be done using an appropriate sized SAD as per the manufacturers recommendations and by an experienced anesthesiologist. During insertion, the following manipulations were allowed: jaw thrust, adjusting insertion depth or head extension, and flexion beyond the sniffing position. If required, any maneuver among the three was opted as per the choice of the anesthesiologist. A maximum of three attempts was allowed. If not successful after three attempts, insertion was considered a failure and an alternative technique was used for airway management and excluded from the study. The appropriate placement was confirmed by proper chest expansion, auscultation, and square waveform on the capnograph. Insertion time was defined as the time from the picking up of the device to the appearance of the first waveform of the end-tidal carbon dioxide. It was calculated by adding the time taken for each attempt, but the time between the two attempts will not be added. We will assess the ease of insertion according to the above-mentioned maneuvers during insertion as follows: easy,fair,difficult. The Ambu AuraGain cuff is inflated and we will note down the cuff pressure(CP). The amount of air required to inflate the cuff, up to 60 cm H2O in PROSEAL LMA, 30cm H2O or 45cm H2O in Ambu AuraGain will be noted for both SADs. OLP will be recorded with the adjustable pressure limiting valve fully closed and oxygen flow maintained at 3 L/min. The pressure at which an audible leak occurred or up to a maximum pressure of 40 cm H2O was noted as OLP. Ventilatory parameters like inspiratory tidal volume (ITV), expiratory tidal volume (ETV), EtCO2, peak airway pressure (PAP) were noted at 1, 5, 15, 30, 60, 90, 120 min after connecting the patient on to the ventilator. Leak percent = ITV-ETV/ITV x 100 is calculated The anatomic position of devices will be evaluated using a fibre-optic bronchoscope and graded on a scale of 1-4 as follows: 1:Vocal cords fully visible; 2: Vocal cords partially visible or arytenoids cartilages visible; 3: Epiglottis visible; 4: No laryngeal structures visible. A well-lubricated gastric tube will be passed through the female port into the gastric access channel of Ambu AuraGain ( F 10 - 12 ) and a drain tube of PROSEAL LMA (F 12 - 14 ). Ease of gastric tube placement will be graded as follows: 1. (easy: one attempt); 2. (difficult: >1 attempt); 3. (impossible). Hemodynamic parameters, SpO2, ETCO2 were noted just before device insertion, 1, 5, 15, 30,60,90,120 min after device insertion and then monitored throughout the surgery Ventilatory Parameters are set according to the weight of the body Maintenance of anaesthesia will be done using O2, N20, Sevoflurane and inj. Atracurium bromide (0.1 mg/kg) IV. After completion of surgery all patient will be reversed with Inj. Neostigmine (0.05 mg/kg) and Inj. Glycopyrolate (0.004 mg/kg) IV. Time taken for removal of SAD will be noted and presence of blood stains is to be observed. Post Operative Vitals at 1, 5, 15, 30,60,90,120 min will be recorded. Complications like Sorethroat, Cough, Nausea, Vomiting, Hoarseness of Voice will be recorded
The main purpose of this trial is to observe which SAD (AMBU AURAGAIN AND PROSEAL LMA) provides better hemodynamic stability and less postoperative complications |