跳至主要内容
临床试验/CTRI/2022/02/040672
CTRI/2022/02/040672已完成不适用

Changes in Optic Nerve Sheath Diameter and Intraocular Pressure as a surrogative marker of postoperative visual loss in patients undergoing surgery in prone position – Prospective Observational study

Melmaruvathur Adhiparasakthi Institute of medical sciences and research1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Theprimary outcome of the study is to investigate the influence of prone position on ONSD of both eyes in patients undergoing surgery under prone position.

研究概览

简要总结

1. Post-operative visual loss (POVL) is an unfortunate, horrifying, and rare complication that is among the legal complaints. It has been mostly reported in surgeries requiring prone position.  Postoperative visual loss (POVL) following prone spine surgery occurs in 0.013% to 1% of cases. In our study we observed significant increase in intraocular pressure and optic nerve sheath diameter during prone postion in spine surgeries which returned to baseline while changing position from prone to supine. No patients developed postoperative visual loss or eye complications in our study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) physical status I , II.

排除标准

  • a.Patient refusal b.Pre-existing eye disease (diabetic retinopathy, corneal opacity, glaucoma and retinal detachment), c.History of eye and neck surgery, d.Trauma patients, e.Haemoglobin ≤ 10g/dl, f.Blood Loss ≥ 1000ml, g.Age > 60 years, h.BMI ≥ 40, i.American Society of Anaesthesia (ASA) physical status III and above, j.Severe anaphylactic allergy to ultrasound gel.

结局指标

主要结局

Theprimary outcome of the study is to investigate the influence of prone position on ONSD of both eyes in patients undergoing surgery under prone position.

时间窗: ONSD of both eyes will measured during Patient awake in supine position before induction of anaesthesia (T0) | 2. Ten minutes after induction of anesthesia and in supine position (T1) | 3. Ten minutes into acquiring prone position (T2) | 4. At the end of the operation in prone position (T3) | 5. Ten minutes into acquiring supine position before the reversal injection and the change in depth of anesthesia (T4)

次要结局

  • 1.To investigate the influence of prone position on IOP of both eyes in patients undergoing surgery under prone position.(2.To find out the influence of age, sex, Body Mass Index (BMI), Peak Inspiratory Pressure (PIP), Mean Arterial Blood Pressure (MAP), Duration of surgery, End Tidal Isoflurane and ETCO2 on IOP and ONSD of both eyes during prone position)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验