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临床试验/NCT04490122
NCT04490122Unknown不适用

Impact of Mode of Anesthesia on Ischemia Modified Albumin (Abiomarker of Oxidative Stress) and Outcome in Patients With Traumatic Brain Injury Undergoing Emergency Craniotomy

Abd-elrahman hassan abd -elaziz0 个研究点目标入组 54 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
54
主要终点
ischemia modified albumin

研究概览

简要总结

In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy

详细描述

After obtaining Institutional Ethical Committee approval and written informed consent from legally acceptable representative relatives, patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery will be selected for this prospective randomized Study.

The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.5 mg/kg atracurium.

Anesthesia will be maintained with:

  • Group I, isoflurane (mac<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.
  • Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.

Parameters will be assessed Preoperative period

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years old of both sex .
  • Isolated traumatic brain injury undergoing emergency craniotomy.
  • G.C.S more than
  • ASA grade (I-III).

排除标准

  • Non traumatic brain injury.
  • Poly trauma patient.
  • Coagulation disorder.
  • Drug( alcohol, opiods, tranquilizers) addiction.
  • Liver and kidney dysfunction.
  • Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders.
  • Diabetes mellitus with poor blood glucose control.
  • Previous drug allergy.
  • Currently lactating.

结局指标

主要结局

ischemia modified albumin

时间窗: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively

Plasma Level of ischemia modified albumin

Glascow Coma Scale

时间窗: change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively

Glascow Coma Scale records the state of a person's consciousness. it gives a person's score between 3 (indicating deep unconsciousness) and 15 (indicating fully consciousness)

次要结局

  • Intraoperative blood pressure.(preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.)
  • Incidence of any complication.(up to 28 days)
  • I.C.U stay.(up to 28 days)
  • I.C.U admission(up to 28 days)
  • Intraoperative heart rate(preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.)

研究者

发起方
Abd-elrahman hassan abd -elaziz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abd-elrahman hassan abd -elaziz

Minia University Hospital

Minia University

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