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临床试验/NCT07747441
NCT07747441招募中不适用

Predictive Value of Baseline Perfusion Index for Spinal Anesthesia-Induced Hypotension in Healthy Patients Undergoing Knee Arthroscopy: A Prospective Observational Trial

Ankara Etlik City Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
2
主要终点
Spinal anesthesia-induced hypotension

研究概览

简要总结

This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy.

Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs.

The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure < 65 mmHg or a decrease in systolic blood pressure > 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-65
  • Having an ASA Score of I-II
  • Including data collection of parts that underwent knee arthroscopy

排除标准

  • Patients under 18 and over 65 years of age
  • Patients with ASA Score III and above

结局指标

主要结局

Spinal anesthesia-induced hypotension

时间窗: During the surgery

Defined as a mean arterial pressure \< 65 mmHg or a decrease in systolic blood pressure \> 25% from baseline

次要结局

  • Investigation of Sensory Block Kinetics(Periprocedural)
  • Vasopressor Consumption(During the surgery)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

İbrahim Topcu

Principal Investigator

Ankara Etlik City Hospital

研究点 (2)

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