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临床试验/NCT02510586
NCT02510586Unknown不适用

Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease

Seoul National University Hospital0 个研究点目标入组 152 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
152
主要终点
The incidence of postoperative cerebral hyperperfusion syndrome

研究概览

简要总结

The aim of the present study is to evaluate the effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome following revascularization surgery in moyamoya patients.

详细描述

Postoperative hyperperfusion syndrome is a common complication in moyamoya disease patients receiving revascularization surgery. Previously its incidence has been reported to be 17~50%, but little remains regarding frequency of reperfusion injury after revascularization surgery in patients with moyamoya disease. Volatile anesthetics such as sevoflurane has been introduced clinically to reduce reperfusion injury and preconditioning with sevoflurane induced ischemic tolerance like as ischemic preconditioning. However, there was no report on the neuroprotective effect of sevoflurane postconditioning on ischemic/reperfusion injury in human brain. Therefore, We evaluated the neuroprotective effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome after revascularization surgery in moyamoya disease patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adult patients receiving cerebral revascularization surgery due to moyamoya disease

排除标准

  • Patients who do not agree to the study
  • Patients with uncontrolled diabetes or hypertension
  • Patients using cyclooxygenase2 inhibitor or with previously using cyclooxygenase2 inhibitor
  • Patients with acute renal failure
  • Patients with previous intervention related with moyamoya disease

研究组 & 干预措施

Sevo_postconditioning

Experimental

Patients receiving sevoflurane 1.0 minimum alveolar concentration (MAC) for 30 minutes after revascularization competed.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

The incidence of postoperative cerebral hyperperfusion syndrome

时间窗: postoperative day 15

Cerebral hyperperfusion syndrome was defined if all the following four criteria were met: i) new development of postoperative focal neurological deficits, ii) a delayed neurological deficits which were not shown in the immediate postoperative period; iii) postoperative reversible neurological deficits which were completely resolved within 15 days after operation; iii) neither definite haematomas nor definite acute infarction on a brain CT scan, on diffusion magnetic resonance imaging, or both.

次要结局

  • The incidence of a new onset postoperative cerebral ischemia(participants will be followed for the duration of hospital stay, an expected average of 3 weeks.)
  • The incidence of a new onset postoperative brain hematoma(participants will be followed for the duration of hospital stay, an expected average of 3 weeks.)
  • The incidence of unrecovered neurological deficit(participants will be followed for the duration of hospital stay, an expected average of 3 weeks.)

研究者

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

Hee-Pyoung Park

Associate Professor

Seoul National University Hospital

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