The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be the maximum intraocular pressure at any time during surgery.
研究概览
简要总结
This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:
Group A - Lactated Ringer's replacement for blood loss and placebo eye drops
Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops
Group C - Albumin replacement for blood loss and placebo eye drops
Group D - Albumin replacement for blood loss and brimonidine eye drops
详细描述
Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spine surgery with instrumentation in prone position expected to last at least 5 hours;
- •Anticipated blood loss ≥ 1L
- •Age 18-80 years old;
- •ASA physical status I-III.
排除标准
- •History of increased intraocular pressure or glaucoma;
- •Diabetic retinopathy;
- •Heart failure or serious left ventricular dysfunction;
- •Abnormal preoperative fundus examination;
- •Creatinine > 2 mg/dL;
- •Patient refuses blood transfusion or albumin administration
结局指标
主要结局
The primary outcome will be the maximum intraocular pressure at any time during surgery.
时间窗: 15 days post surgery
次要结局
- Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.(15 days post surgery)