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临床试验/NCT00695890
NCT00695890已完成不适用

Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.

University of Medicine and Dentistry of New Jersey1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

研究概览

简要总结

Null hypothesis (HO): There will be no difference in pupillometry readings when using any of the maintenance anesthetic techniques within subjects.

Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the anesthetic technique

详细描述

Postoperative visual loss resulting from a surgical procedure not performed on the eye is a devastating outcome for the patient and poorly understood by the medical community. It is potentially a preventable complication. Diminished blood supply to the optic nerve, affecting both the anterior or posterior portions of the optic nerve, is the most common cause of postoperative visual loss. Other, less common causes include occlusion of the retinal artery and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual loss increases in patients undergoing cardiopulmonary bypass and prone spine surgery. Although the etiology of post-operative visual loss is unknown, it is thought to be multifactorial, and several potential risk factors have been identified, including degree of low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood loss, prolonged duration of surgical time and increased pressure in the eye associated with positioning. To date studies have focused on the mechanism associated with the visual loss. We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18 and 70 years of age who are mentally capable of providing an informed consent and who are medically classified as ASA 1 or
  • Planned elective orthopedic extremity surgery in the supine position with the head in the neutral position.

排除标准

  • Failure to provide an informed consent
  • Known history of eye disease which cannot be corrected with lenses
  • Surgery lasting less than 45 minutes

结局指标

主要结局

We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

时间窗: 18 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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