Comparison of postoperative sore throat following two type of airway device insertion in laparoscopic day care surgery

Phase 4

Not yet recruiting

• Conditions: Disorders of gallbladder, biliary tract and pancreas,

• Registration Number: CTRI/2025/06/089275
• Lead Sponsor: AIIMS

Brief Summary

General anaesthesia is widely practiced for laparoscopic abdominal surgery as pneumoperitoneum increases the risk of pulmonary aspiration., and this typically facilitated using an endotracheal tube (ETT) for airway management. But many of these laparoscopic surgeries are day care surgeries and used of ETT in these cases can lead to cumbersome postoperative pharyngodynia thereby increasing the duration of hospital stay and thereby increasing the health care cost. Hence now a days supraglottic airway devices (SGA) are preferred over ETT in these daycare cases because of less incidence of post operative pharyngodynia. However still many cases postoperative pharyngodynia occurs despite using second generation SGA because of variable intracuff pressure of SGA perioperatively. This change in intracuff pressure occurs due to change in patient positioning and creation of pneumoperitoneum perioperatively. Recently introduced The LMA Protector has dual gastric access and integrates “Second Seal Technology/second generation LMA” to secure the distal tip at the upper oesophageal sphincter. In this way an oesophageal seal is facilitated, and the respiratory tract is isolated from the digestive tract.[3] It also has inbuilt color-coded continuous cuff pressure monitoring system. Despite these developments, the scarcity of prospective research examining the suitability of different second-generation SGA which will cause less postoperative pharyngodynia and decrease hospital stay in day care surgery underscores the need for further investigation. Therefore, this study aims to evaluate the feasibility and safety of employing two second-generation SGA namely LMA Protector and Ambu AuraGain in patients undergoing laparoscopic surgeries, addressing a critical gap in the literature, and informing clinical practice regarding optimal airway management strategies in this context.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-19
• Study Start: 2025-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age more thab 18 years Patient for day care laparoscopic surgeries.

Exclusion Criteria

Unwillingness to provide consent ASA 1 and 2 Body mass index more than 35 kg/m2 Patients with known risk factors for aspiration like GERD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative sore throat or pharyngodynia	1 hr after Supraglottic airway device removal

Secondary Outcome Measures

Name	Time	Method
Oropharyngeal leak Pressure	After successful supraglottic airway device insertion
To compare dysphagia and post operative nausea vomiting between the two groups.
To compare the insertion time and number of attempts required for insertion between the two groups	3 Minutes after induction
3.To compare respiratory mechanics peak airway pressure (Ppeak), plateau airway pressure (Pplat), PEEP, set TV (TV set), actual TV (TV act)	after induction, 5 minutes after pneumoperitoneum, 5 minutes after stopping pneumoperitoneum and at the end of surgery
To compare change in intracuff pressure	after induction, 5 minutes after pneumoperitoneum, 5 minutes after stopping pneumoperitoneum and at the end of surgery

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

DR SUBODH KUMAR

Principal investigator

09793184350

subodh.08aiims@gmail.com