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脊髓麻醉期间上肢位置与眼内压 (UEP-IOP)

2026年9月25日 更新者:Elazıg Fethi Sekin Sehir Hastanesi

上肢位置对开放腹股沟疝修补术中脊髓麻醉期间眼压影响的随机对照试验

This prospective randomized controlled trial evaluated the effect of two upper extremity positions on intraocular pressure (IOP) in adult patients undergoing surgery under spinal anesthesia. Participants were randomly assigned to either an arms-at-sides position or a hands-on-chest position. IOP was measured in the right eye using an Icare ic200 rebound tonometer at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure, heart rate, and oxygen saturation, were also recorded. The primary outcome was the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position between the two upper extremity position groups.

研究概览

详细说明

Intraocular pressure (IOP) may be influenced by systemic hemodynamics, venous return, episcleral venous pressure, and patient positioning. Although the effects of head and body position on IOP have been investigated, the impact of upper extremity positioning during spinal anesthesia has not been clearly established. This prospective randomized controlled trial was conducted at Elazig Fethi Sekin City Hospital. Adult patients scheduled for elective surgery under spinal anesthesia were enrolled. After written informed consent, participants were randomly assigned to one of two upper extremity positions: arms positioned alongside the body or hands positioned on the chest. IOP was measured in the right eye using an Icare ic200 rebound tonometer. Measurements were obtained at baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before application of the assigned upper extremity position, and 30 minutes after application of the assigned position (approximately 45 minutes after spinal anesthesia). Head and neck position was maintained neutral throughout the measurement period. Hemodynamic parameters, including mean arterial pressure, heart rate, and peripheral oxygen saturation, were recorded simultaneously. The primary outcome was the between-group comparison of the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position. Secondary outcomes included IOP change at 15 minutes and perioperative hemodynamic changes.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Outside of the US
      • Elâzığ、Outside of the US、土耳其(türkiye)、23200
        • Elazığ Fethi Sekin City Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 18 and 80 years
  • ASA physical status I-III
  • Scheduled for elective open inguinal hernia repair under spinal anesthesia
  • Ability to undergo intraocular pressure measurement
  • Provision of written informed consent

Exclusion Criteria:

  • History of glaucoma or ocular hypertension
  • Previous ocular surgery or ocular trauma
  • Active ocular disease or infection
  • Contraindication to spinal anesthesia
  • Inability to cooperate with intraocular pressure measurements
  • Refusal to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Arms-at-Sides Position

Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both arms were positioned alongside the body, parallel to the torso, with the palms facing upward, and this position was maintained for approximately 30 minutes until the final T45 measurement.

Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement.

实验性的:Hands-on-Chest Position

Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both upper extremities were adducted with the elbows flexed, and the open hands were placed one over the other on the anterior chest wall. This position was maintained for approximately 30 minutes until the final T45 measurement.

Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Intraocular Pressure From Baseline to 30 Minutes
大体时间:Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)

Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. The primary outcome was the change in intraocular pressure from baseline before spinal anesthesia to 30 minutes after application of the assigned upper extremity position between the two study groups.

Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)

次要结果测量

结果测量
措施说明
大体时间
Change in Intraocular Pressure From Baseline to 15 Minutes
大体时间:Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position

Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. This secondary outcome was the change in intraocular pressure from baseline to 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position, between the two study groups.

Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
Mean Arterial Pressure
大体时间:Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)

Mean arterial pressure was recorded simultaneously with the intraocular pressure measurements and evaluated between the two study groups.

Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月20日

初级完成 (实际的)

2026年2月10日

研究完成 (实际的)

2026年2月10日

研究注册日期

首次提交

2026年2月12日

首先提交符合 QC 标准的

2026年2月14日

首次发布 (实际的)

2026年2月20日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • EFSH-ANES-IOP-RCT-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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