Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- The change of intraocular pressure
研究概览
简要总结
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.
详细描述
In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective spine surgery in prone position under general anesthesia
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Have signed consent form
排除标准
- •History of eye disease or eye surgery
- •Pregnancy or breast feeding
- •Known Allergy to latex or Ringer's lactate solution
- •Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
- •Body mass index（BMI）>30
- •Expected operation time >6 hours
- •Estimated Intraoperative hemorrhage >1000ml
- •Taking part in other clinical trials in the last 3 months or at present
结局指标
主要结局
The change of intraocular pressure
时间窗: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).
Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer.
次要结局
- The change of the optic sheath diameter(10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).)
研究者
Xiao-Yu Yang, MD
Principal Investigator
Huashan Hospital