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临床试验/NCT04094974
NCT04094974已完成不适用

The Usefulness of the Combination of Preoperative Assessment of Optic Nerve Sheath Diameter and Heart Rate Variability to Predict Intraoperative Brain Condition in Patients With Supratentorial Tumors

DyAnsys, Inc.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
DyAnsys, Inc.
入组人数
58
试验地点
1
主要终点
Brain relaxation

研究概览

简要总结

This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.

详细描述

Patients undergoing brain surgery for treatment of brain tumors will be studied to determine the relationship between heart rate variability and intraoperative brain relaxation conditions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 18 to 75 years
  • ASA(American Society of Anesthesiologists ) I - III
  • Patients undergoing surgery for supratentorial tumors
  • Glasgow coma scale > 10

排除标准

  • Patient aged below 18 and above 75 years.
  • Pregnancy
  • ASA(American Society of Anesthesiologists) IV-V
  • Previous cranial surgery
  • Morbid obesity ( BMI>40)
  • Ocular injury/ Glaucoma
  • Head injury
  • Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine
  • Diabetes mellitus for more than 5 years

结局指标

主要结局

Brain relaxation

时间窗: 2hours

1. Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined. 2. Brain surface at level of craniotomy margins, Brain pulsations faintly observed 3. Brain surface just below the surface of craniotomy margin. Brain pulsations well seen. 4. Brain surface well below the surface of craniotomy margin, well retracted in to the cranial cavity with good brain pulsations.Brain relaxation score will me measured only once. There is no follow up

次要结局

  • Hemodynamic Measurement-Heartrate(2hours)
  • Hemodynamic Measurement-Bloodpressure(2hours)

研究者

发起方
DyAnsys, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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