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临床试验/CTRI/2025/05/087275
CTRI/2025/05/087275尚未招募4 期

A Study To Assess Efficacy Of Blockbuster LMA For Ventilation And Intubation

Dr Shahil ahmed1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年5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
200
试验地点
1
主要终点
•To study the first attempt successful intubation done using blockbuster LMAs and NG insertion.

研究概览

简要总结

The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion Criteria planned for short surgeries under GA. Material used were Blockbuster LMA, Anaesthesia workstation, suction apparatus, Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient. The study population is divided into single group of 200 patients. Group B used Blockbuster as ventilatory device. In the operating room, an 18G IV cannula is inserted into both hands. Ringer lactate solution is infused at 10ml/kg. Patients receive 100% oxygen for 3 minutes, followed by premedication. Standard monitoring is connected. Anesthesia is induced with propofol and vecuronium and maintained with oxygen, nitrous oxide, and sevoflurane after introducing allocated SAD. parameters like-successful insertion time, number of attempts of insertion, oropharyngeal leak pressure and vitals like- pulse rate, blood pressure, SpO2 , EtCO2 and ventilator parameters will be noted before induction of anesthesia, throughout surgery and immediately after removal of the device after completion of surgery

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Patients giving informed written consent for participation in the study.
  • 2.Patients posted for surgery under general anesthesia.
  • 3.Age of the patient between 18-65 of either sex.
  • 4.Patients belonging to American Society of Anaesthesiology class I and II.
  • 5.Patients belonging to Modified Mallampatti Score of class I and II.

排除标准

  • 未提供

结局指标

主要结局

•To study the first attempt successful intubation done using blockbuster LMAs and NG insertion.

时间窗: 24hrs

次要结局

  • •The time of LMA insertion & LMA removal.(•Any intra-op & post-op complications occurring using LMAs.)

研究者

发起方
Dr Shahil ahmed
申办方类型
Other [self]

研究点 (1)

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