Comparison of oropharyngeal leak pressure between the I-gel®, Blockbuster® and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population. A randomised controlled trial

This study is a randomized controlled trial regarding the comparison of oropharyngeal leak pressure between the I-Gel®, Blockbuster®, and Baska Mask supraglottic airway devices during general anaesthesia in the elderly population.The elderly population often presents unique challenges during general anaesthesia due to age-related anatomical and physiological changes.Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during general anesthesia. Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in the elderly population undergoing general anesthesia.The sample size was calculated based on the study by Chi et al.; a sample size of 108 patients (36 per group) will be taken, considering dropouts and errors in the sample size calculation.convenient sampling1. The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during general anaesthesia among the elderly age group, and the secondary objective is to evaluate and compare the insertion time,the peak pressure, the number of manoeuvres used during insertion, and the intraoperative and postoperative anesthesia-related problems.The inclusion criteria include patients over 65 years of age, ASA physical status I–II,elective surgery under GA with an anticipated duration of <2 hours in the supine position, and the exclusion criteria exclude patients undergoing laparoscopic surgery,reduced mouth opening (interincisor distance <4 cm), recent history of upper respiratory tract infection, BMI > 35, and severe symptomatic esophageal reflux diseases.

Patients meeting the inclusion criteria will be transferred to the operating room (OR).Upon arriving inside the OR, all standard ASA monitors will be attached, and recording of the baseline hemodynamic parameters will be noted.Before inducing the patient, sealed opaque envelopes with allocated groups will be handed over to the anesthesiologist, and the patient will be induced under general anesthesia. An appropriate size of SADs (as per the group allocated) will be inserted. . The size of the SADs will be selected according to the weight of the patient as per the manufacturer’s recommendation. When an audible leak is detected and/or the pressure gauge on the anaesthesia machine displays a stable airway pressure, the value will be recorded as the sealing pressure has been reached. Oropharyngeal leak pressure will be measured by closing the pressure release valve and opening fresh gas flow at 3 L/minute. They won’t be permitted to go over 40 cm H2O. .Two readings of OLP and peak pressure will be taken, one after 5 minutes of insertion of SADs (T1) and the other 20 minutes after insertion.(T2)