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临床试验/CTRI/2024/10/074726
CTRI/2024/10/074726尚未招募2/3 期

A COMPARATIVE STUDY OF CLINICAL PERFORMANCE OF I-GEL AND LMA- BLOCKBUSTER IN ADULT PATIENTS UNDERGOING ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA

LLRM medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1. To see the ease of insertion

研究概览

简要总结

A  comparative study between efficiency of I-GEL and Block buster LMA in adults patients undergoing elective surgery. We conducted this study for 2 years . We compared changes in hemodynamic parameters , oropharyngeal airway seal and other complications. This study conducted in healthy patients with minimum comorbidities.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Anticipated normal airway in preanaesthetic evaluation
  • Age 18-65 years of either sex
  • Adult patients undergoing elective surgeries under general anaesthesia
  • BMI 18-24
  • Hemodynamically stable patients.

排除标准

  • Anticipated difficult airway
  • Anticipated high risk of aspiration ( hiatus hernia, Full stomach, GERD, Pregnancy
  • Bleeding and Coagulation disorders
  • Patients with any severe systemic disease
  • Patients undergoing emergency surgery
  • History of Obstructive sleep apnea.

结局指标

主要结局

1. To see the ease of insertion

时间窗: Baseline hemodynamics changes every 1,3,5 ,15 minutes and then every 15 minutes till end of surgery | Oropharyngeal leak pressure after correct placement (around 10 minutes)

2. Assessment of hemodynamic changes (HR, SBP, DBP, Spo2)

时间窗: Baseline hemodynamics changes every 1,3,5 ,15 minutes and then every 15 minutes till end of surgery | Oropharyngeal leak pressure after correct placement (around 10 minutes)

3. Oropharyngeal leak pressure

时间窗: Baseline hemodynamics changes every 1,3,5 ,15 minutes and then every 15 minutes till end of surgery | Oropharyngeal leak pressure after correct placement (around 10 minutes)

次要结局

  • 1. Trauma to airway during insertion(2. Postoperative sore throat)

研究者

发起方
LLRM medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Neha Singh

LLRM Medical College

研究点 (1)

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