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临床试验/NCT03714347
NCT03714347Unknown不适用

The Effect of Cerebral Oxygenation on Postoperative Recovery in Intracranial Surgery

Trakya University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年12月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
cerebral oxygen monitoring data

研究概览

简要总结

The aim of this study was to investigate the effect of cerebral oxygenation on postoperative compilation in intracranial surgery.

详细描述

Patients undergoing intracranial surgery will be divided into two groups; group (Group Control n = 100) and cerebral oxygenation monitoring group (Group Oxygen). all hemodynamic parameters such as systolic blood pressure and diastolic blood pressure, oxygen saturation, Et CO2, SpO2;% and BIS during anesthesia during anesthesia will be recorded intraoperatively and 10 postoperatively in 5 min intervals. After extubation, Modified Aldrete Score, GKS (Glasgow Coma Scale), Ramsey Sedation Scale (RSS), nausea-vomiting and pain will be recorded in the recovery room. Pain assessment will be done with Visual Analog Scale (VAS). Patient satisfaction will be recorded. MMST (mini mental state test) and ASEM (antisaccadic eye movement test) tests will be performed preoperatively and postoperatively at 1st, 2nd and 3rd days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Intracranial surgery will be performed
  • Age 25-75
  • ASA in the I-II-III risk group

排除标准

  • Under GKS 15
  • heart failure,
  • renal insufficiency,
  • liver failure,
  • congenital neurological deficits

研究组 & 干预措施

Group Control

Active Comparator

routine monitoring will be applied to this group

干预措施: routine monitoring (Device)

Group Oxygen

Active Comparator

cerebral oxygen monitoring is applied to this group

干预措施: cerebral oxygen monitoring (Device)

结局指标

主要结局

cerebral oxygen monitoring data

时间窗: cerebral oxygen values reported will be measured at 10 min intervals (intraoperative) and It would be reported by the first postoperative 10 minute intervals up to 30 minutes

cerebral oxygen monitoring will measure peroperative

次要结局

未报告次要终点

研究者

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

Sevtap Hekimoglu Sahin

Clinical Professor

Trakya University

研究点 (2)

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