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临床试验/NCT04582227
NCT04582227已完成不适用

The Effect of Using Ambu Aura-i Laryngeal Mask Airway Versus Endotracheal Tube on Emergence Hypertension in Supratentorial Cranial Surgery: A Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Measure Mean blood pressure

研究概览

简要总结

the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.

详细描述

In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
  • Aged 18 to 60 years.

排除标准

  • Patients who are known hypertensive, history of cardiac diseases or chest diseases
  • Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
  • Risk of difficult intubation
  • Extensive intracranial tumours that may affect recovery of patients.

结局指标

主要结局

Measure Mean blood pressure

时间窗: UP TO 1 HOURE

incidence of emergence hypertension

次要结局

  • successful placement of the airway device(UP TO 1 HOURE)
  • incidence of postoperative complication(up to 24 hours)
  • Measure Mean Heart rate(UP TO 1 HOURE)
  • amount of fentanyl(up to 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

研究点 (1)

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