To compare the safety & efficacy of ProsealLMA versus i-gel in children undergoing elective surgery under spontaneous ventilation: A randomized control trial

The Laryngeal mask airways are supraglottic airway devices that has gained popularity over years in managing difficult airway,nonoperating room anaesthesia,day care surgeries,ophthalmologic surgeries, etc.These devices have been designed to provide and maintain seal around laryngeal inlet and are considered effective alternatives to endotracheal tube. The relatively newer second generation such as LMAs such as proseal LMA and i-gel  are used widely in children. The  objective of this study is to compare the efficacy and safety of their use in paediatric population undergoing elective surgeries in terms of  successful airway placement,oropharyngeal leak pressure, gastric tube insertion, ease of insertion and complications anticipated during spontaneous ventilation and postoperatively

All children aged between 1 to 10years scheduled for elective surgeries with duration less than 2hr,BMI<30 and with ASA physical status of I and II meeting the inclusion criteria will be included. After informed consent, eligible patients will be advised fasting orders for solids and liquids and will be randomly allocated on the day of surgery by opaque envelope concealment method. After securing a good intravenous access after inhalational induction and connecting ASA standard monitors, the child will be deepened for LMA insertion with  intravenous agents like fentanyl (1-2 mcg/kg)and propofol (1-2 mg/kg).The successful placement of LMA will be assessed on ease of insertion of LMA ,acquiring adequate tidal volumes, oropharyngeal leak pressure, ease of gastric tube insertion, any laryngospasm during induction and maintenance will be observed and after extubation staining of LMA with blood and sore throat ,hoarse cry,discomfort in throat will be observed in postanaesthesia care unit.

There are very few studies comparing proseal LMA and i-gel in paediatric population under spontaneous ventilation.Proseal LMA is considered as standard of care and from this study if i-gel proves to be noninferior to Proseal LMA,it may be used alternatively in future elective surgical day to day practices.