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临床试验/CTRI/2024/09/073288
CTRI/2024/09/073288尚未招募4 期

Comparison of efficacy and safety of I gel and Blockbuster Laryngeal Mask Airway for their insertion characteristics and oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia A randomised single blinded clinical study

Dept of Anaesthesiology,RNT Medical College1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月15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
66
试验地点
1
主要终点
Oropharyngeal Leak pressure

研究概览

简要总结

My clinical study titled-Comparison of efficacy and safety of I-gel and Blockbuster Laryngeal Mask Airway for their insertion characteristics and oropharyngeal leak pressure in patients undergoing laparoscopic cholecystectomy under general anaesthesia: A randomised single-blinded clinical study. Our primary objective will be comparison of oropharyngeal leak pressure and secondary objective will be comparison of Ease of insertion, Time of insertion, Number of attempts at insertion, Haemodynamic changes, Complications, if any and Number of attempts at nasogastric tube insertion.Kindly consider it for CTRI registration.

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
All

入选标准

  • Patients with ASA-PS 1 or 2 Duration of surgery less than 90 minutes.

排除标准

  • Patient Refusal
  • Patients with ASA PS 3 and above.
  • Silicone allergy
  • Patients who have received oxygen support or mechanical ventilation in the past one month
  • Patients with risk factors for difficult airway
  • Any known pulmonary disease or cardiovascular disease.
  • Risk of aspiration
  • Pregnant females
  • Patients with BMI more than 25 kg per metre square.

结局指标

主要结局

Oropharyngeal Leak pressure

时间窗: Immediately after securing the airway (5min after Procedure)

次要结局

  • Ease of insertion,time of insertion, number of attempts at insertion, hemodynamic changes, complications if any, number of attempts at nasogastric tube insertion(After successful insertion of the airway uptil 90 min)

研究者

发起方
Dept of Anaesthesiology,RNT Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Surendra Kumar Sethi

R.N.T. Medical College, Udaipur

研究点 (1)

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