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临床试验/CTRI/2024/03/064517
CTRI/2024/03/064517尚未招募3 期

Comparing The Efficacy OF I-GEL, PROSEAL LMA and BASKA MASK with respect to airway dynamics in patients undergoing laproscopic cholecystectomy under General Anaesthesia. A Randomised Controlled Trial

DR SN MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To compare the changes in dynamic compliance at different time intervals using I-GEL, proseal, Baska mask in patient undergoing elective laproscopic cholecystectomy under general anaesthesia

研究概览

简要总结

laproscopic resection of gall bladder has become a standard technique for cholecystectomy due to its less invasive nature. tracheal intubation, though considered as ideal mode of ventilation, has various disadvantages such as increased sympathetic response during tracheal intubation, pneumoperitoneum and extubation.  trends have nowadays progressed from the use of endotracheal tube to supraglottic airway devices because of quick placement in the airway, decreased airway manipulation  and stable  hemodynamics, decreased requirement of neuromuscular blockade, along with lower incidence of postoperative complications such as sore throat, dysphagia and dysphonia.

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
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • the patients with age group 20 to 65 years with BMI between 18.5 to 29.9kg/m2 belonging to ASA grade I and II with mallampati class either I or II undergoing elective laproscopic cholecystectomy under general anaesthesia.

排除标准

  • patient with anticipated difficult intubation with mouth opening less than 3 cm and thyromental distance less than 6.5cm patient who are pregnant confirmed by urine pregnancy test patient had history of gastric regurgitation had taken treatment in past or on treatment patient having emergency surgery.

结局指标

主要结局

To compare the changes in dynamic compliance at different time intervals using I-GEL, proseal, Baska mask in patient undergoing elective laproscopic cholecystectomy under general anaesthesia

时间窗: at the time of insertion of device, after 5 mins of insertion of device, at time of pneumoperitoneum, 30 mins after pneumoperitoneum, 5 mins after removal of pneumoperitoneum

次要结局

  • to compare changes in oropharyngeal leak pressure(at the insertion of device, after 5 mins of insertion of device, at pneumoperitoneum, 30 mins after pneumoperitoneum, at 5 min afterr release of pneumoperitoneum)
  • to compare insertion time(time between picking a device and obtaining a proper airway)
  • number of attempts(maximum 3 attempts allowed)
  • hemodynamic parameters(before insertion of device.)

研究者

发起方
DR SN MEDICAL COLLEGE
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR Fateh Singh Bhati

DR. S.N. MEDICALCOLLEGE

研究点 (1)

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