Upper Extremity Position and Intraocular Pressure During Spinal Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure
研究概览
简要总结
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 between the two upper extremity position groups.
详细描述
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, 15 minutes, and 30 minutes after spinal anesthesia and positioning. 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 change in IOP from baseline to 30 minutes between the two study groups. Secondary outcomes included IOP change at 15 minutes and perioperative hemodynamic changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and care providers could not be blinded. However, intraocular pressure measurements were performed by an outcome assessor blinded to group allocation.
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
- •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
排除标准
- •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
结局指标
主要结局
Change in Intraocular Pressure
时间窗: From baseline (T0, before spinal anesthesia) to recovery unit (T6), during the intraoperative period (approximately 60-90 minutes).
Intraocular pressure measured bilaterally using a Tono-Pen AVIA tonometer at predefined time points (T0-T6) during spinal anesthesia and surgery.
次要结局
未报告次要终点