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临床试验/CTRI/2025/06/089275
CTRI/2025/06/089275尚未招募4 期

Evaluation of Second-generation laryngeal mask airway (LMA Protector) for laparoscopic surgeries – A Randomized Controlled Trial

AIIMS1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
AIIMS
入组人数
150
试验地点
1
主要终点
Incidence and severity of postoperative sore throat or pharyngodynia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Incidence and severity of postoperative sore throat or pharyngodynia

时间窗: 1 hr after Supraglottic airway device removal

次要结局

  • 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)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital

研究点 (1)

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