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临床试验/CTRI/2024/06/069014
CTRI/2024/06/069014尚未招募不适用

An observational comparative study to evaluate the ocular changes in patients undergoing spine surgery in prone position under Total Intravenous Anaesthesia versus Balanced Anaesthesia

Operation TheatreM S Ramaiah medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Measure the Intraocular pressure at various intervals in both groups to observe and compare the better outcome of ocular changes

研究概览

简要总结

We propose to conduct a observational comparative study of the ocular pressure changes- intraocular pressure(IOP),mean arterial pressure( MAP) ,ocular perfusion pressure(OPP)  in patients undergoing spine surgery in prone position when maintained intraoperatively under Total intravenous anaesthesia versus  Balanced Anaesthesia. Prone  position is used for posterior approach in spine surgery, such positioning is known to cause ocular changes due to pressure on the orbital content and the altered hemodynamics(MAP) leading to increase intraocular blood volume thus IOP and OPP; hypoxia to optic nerve, ischemic optic neuropathy ,visual loss are some of the ocular changes observed. Thus the study is done in comparison to establish a protocol to prevent and anticipate the ocular changes. Patients will undergo pre anaesthetic checkup prior to surgery. Informed consent will be obtained from patients who meet the inclusion criteria. We will measure IOP, MAP, HR before induction, 5 min after induction and at the end in supine position, 5 min after extubation then OPP will be calculated from IOP and MAP, post-operative outcome and any adverse events during the surgery will be recorded.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing spine surgery (thoracolumbar)
  • Less than 4 hours duration of surgery
  • Prone position 4.

排除标准

  • Refusal to consent for proposed study,
  • ASA III &IV
  • Any history of Glaucoma
  • Any ocular surgery(less than 3 months)
  • Cervical spine surgery 6.

结局指标

主要结局

Measure the Intraocular pressure at various intervals in both groups to observe and compare the better outcome of ocular changes

时间窗: IOP1-before induction | IOP2- 5 min After induction | IOP3- 5 min After Supine position at the end of surgery | IOP4- 5 min After extubation

次要结局

  • heart rate, mean arterial pressure,SpO2(Time(mins))

研究者

发起方
Operation TheatreM S Ramaiah medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR SANDHYA B K

M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL(RUAS)

研究点 (1)

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