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临床试验/NCT03129009
NCT03129009Unknown不适用

Changes of Hemodynamics and Vital Organ Function in Intracerebral Hemorrhage During Different General Anesthesia

Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
MAP changes relative to the changes before induction

研究概览

简要总结

Spontaneous non-traumatic intracerebral hemorrhage (ICH) is a common symptom in clinical practice and is the most serious among all types of stroke.Recently, as a relatively mainstream and recognized INTERACT2 (five well-known international studies in the cerebrovascular field: IMS-III, MR RESCUE, SYNTHESIS EXPANSION, INTERACT2, CHANCE) studies have shown that in patients with standard systolic blood pressure Early intensive antihypertensive therapy does not increase the incidence of death or serious adverse events. The above studies confirm the safety and efficacy of early potent depression.In 2017, Anesthesiology published a META analysis of intraoperative hypotension and blood pressure versus baseline fluctuations. The final outcome showed that 20% of blood pressure in the study was similar to MAP <65 mmHg, regardless of the duration of the duration There will be postoperative myocardial and renal damage. Ischemia is a very important cause of organ damage. Myocardial injury is closely related to the level of mean arterial pressure, while ischemia and ischemic reperfusion injury are closely related to postoperative acute renal injury.There is no targeted guideline for ICH perioperative blood pressure management, especially intraoperative blood pressure management, and no previous studies have studied most of the studies involving ICH patients with conservative treatment, ICH patients with surgical treatment There are few reports on blood pressure control during surgery.

详细描述

The general anesthesia used in craniotomy, whether intravenous anesthesia or total intravenous anesthesia, have a certain degree of blood pressure and lead to a decline in blood pressure, the study aims to spontaneous cerebral hemorrhage this special And to observe the changes of hemodynamics and the changes of heart and kidney function in ICH, and to explore the relationship between the anesthesia and the blood of ICH. The range of volatility.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years to90 years.
  • acute stroke symptoms caused by initial spontaneous intracerebral hemorrhage as determined by CT or MRI Blood: the screen area: 30-50ml; cerebellum parts:> 10ml.
  • GCS score> 5 points

排除标准

  • ICH is caused by other factors (anticoagulation associated with cerebral hemorrhage, arteriovenous malformations, tumors)
  • intracerebral hematoma is thought to be associated with trauma (simple intracerebral hemorrhage)
  • there are surgical contraindications.
  • history of ischemic stroke
  • acute spontaneous intracerebral hemorrhage before the presence of dementia or limb dysfunction (paralysis or aphasia.
  • preoperative combined with chronic kidney disease (standard for glomerular filtration rate below 60 ml · min-1 · 1.73 m2 or received dialysis).
  • anesthesia time shorter than 60 min or lack of relevant basic information.
  • while there is interference with the experimental results or follow-up of the disease (tumor, severe cardiovascular disease).

研究组 & 干预措施

Total intravenous anesthesia group

Active Comparator

Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion

干预措施: Total intravenous anesthesia group (Drug)

Balanced anesthesia group

Experimental

Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation

干预措施: Balanced anesthesia group (Drug)

结局指标

主要结局

MAP changes relative to the changes before induction

时间窗: Intraoperative

MAP changes relative to the changes before induction; \<20%, 20% -30%, 30% -40%,\> 40%MAP changes relative to the changes before induction; \<20%, 20% -30%, 30% -40%,\> 40%

次要结局

  • Acute renal failure(7 days post surgery)
  • Troponin T(6 hour, 12 hour, 24 hour, 48 hour post surgery)
  • CK-MB release level(6 hour, 12 hour,24 hour,48 hour post surgery)
  • Serum creatinine(24 hour, 48 hour,72 hour post surgery)
  • All-cause mortality(7 days post surgery)

研究者

发起方
Xuzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Dong Liu

Principal Investigator

Xuzhou Medical University

研究点 (1)

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