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临床试验/CTRI/2024/02/062633
CTRI/2024/02/062633尚未招募4 期

Efficacy of I gel®, Baska Mask and Blockbuster® LMA for the airway management in laparoscopic gynaecological surgeries: A Randomized controlled trial.

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年2月29日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
99
试验地点
1
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

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 in laparoscopic gynaecological surgeries.The laparoscopic gynaecological surgeries often presents unique challenges during general anaesthesia due to trendelenburg position and pneumoperitoneum  .Oropharyngeal leak pressure (OLP) is an essential indicator of airway seal and is directly correlated with successful ventilation during laparoscopic gynaecological surgeries . Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in laroscopic gynaecological surgeries.

Research hypothesis is we hypothesise that Baska Mask and Blockbuster SAD will have a higher OLP as compared to I gel in patients undergoing laparoscopic gynaecological surgery.

The primary objective is to compare the oropharyngeal leak pressure between I-gel®, Blockbuster®, and Baska Mask during laparoscopic gynaecological surgeries, and the secondary objective is to evaluate and compare: The peak pressure before and after pneumoperitoneum, Insertion attempt, Insertion time, Number and type of airway manipulation required, Perioperative and postoperative anaesthesia related problems.

The inclusion criteria include patients between 18 to 60 years of age, ASA physical status I–II, BMI 18 to 30, and the exclusion criteria include Patient refusal, Anticipated difficult airway, History of gastroesophageal reflux diseases, Patients with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure., Expected duration of surgery > 3 hours, Any surgery with expected postoperative ICU admission.

The sample size was calculated based on the study by Jeon WJ et al. a sample size of 99 patients (33 each group) will be taken, considering dropouts and errors in the sample size calculation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA physical status I & II
  • BMI: 18 to 30.

排除标准

  • Patient refusal
  • Anticipated difficult airway
  • History of gastroesophageal reflux diseases
  • Patients with previous abdominal surgery or comorbidities that would affect surgical time, time under anaesthesia, intragastric pressure and abdominal pressure.
  • Expected duration of surgery more than 3 hours.
  • Any surgery with expected postoperative ICU admission.

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: T1: After successful insertion of the SAD | T2: 15 minutes after pneumoperitonium and Trendelenburg position | T3: 1 hour after pneumoperitonium and Trendelenburg position

次要结局

  • Peak pressure(Insertion attempt)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Preeti

AIIMS PATNA

研究点 (1)

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