跳至主要内容
临床试验/CTRI/2025/04/084002
CTRI/2025/04/084002尚未招募不适用

Evaluation of Ease of Insertion and Successful Placement of I-Gel and Ambu Aura Gain In Spontaneously Breathing Anaesthetized Patient

Gandhi Medical College Bhopal Madhya Pradesh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To determine the ease and success rate of Ambu Auragain

研究概览

简要总结

Standard anaesthesia monitoring will be established  iv access will be secured  The anaesthesia protocol will be standard patient will be preoxygenated with 100% oxygen then anaesthesia will be induced by premedication with glycopyrolate midazolom  fentanyl and induction  propofol till loss of verbal response then  SGA  will be inserted and Patients will be ventilated with oxygen and sevoflurane 2% for 3 min After  checking adequate ventilation patient is kept on spontaneous respiration while maintaining anesthesia with oxygen+N2O+sevoflurane 2-3%  Ease of SGA devices  insertion will be graded according to subject handling score easy  satisfactory  difficulty Time of successful SGA devices will be measured from insertion of SGA devices from dental arches until confirmation of successful ventilation T1  Number of attempts and manoeuvres required for SGA devices insertion will be  recorded  Maximum 2 attempts for SGA devices insertion will be taken and will be proceeded for alternative technique or endotracheal intubation depanding upon decision of anaesthesiologist

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA grade l and ll Age group 20 to 60 year All patients scheduled to undergo elective surgery in the supine position with spontaneous respiration Duration of surgery less than one hr.

排除标准

  • Patients with known difficult airways Cervical spine disease Mouth opening less than 2 cm History of upper gastrointestinal bleeding or clotting abnormalities gastroesophageal reflux disease Excluded in the study.

结局指标

主要结局

To determine the ease and success rate of Ambu Auragain

时间窗: SGA insertion time after 1 min 5 min 15 min and after SGA removal number of attempts leak pressure and ease of placement will be assessed

and I-gel in patients for short surgical procedures with Spontaneous respiration

时间窗: SGA insertion time after 1 min 5 min 15 min and after SGA removal number of attempts leak pressure and ease of placement will be assessed

次要结局

  • To observe Variation in haemodynamic parameters.(Vital monitoring baseline after induction after insertion for 1 min 5 min 15 min after removal of SGA)

研究者

发起方
Gandhi Medical College Bhopal Madhya Pradesh
申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验