跳至主要内容
临床试验/NCT07302061
NCT07302061进行中(未招募)不适用

"Effects of Fluid Status and Regional Cerebral Oxygenation on Postoperative Cognitive Dysfunction in Patients Undergoing Lower Extremity Surgery Under General and Spinal Anesthesia."

Goztepe Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Early postoperative period (24th and 48th hours) cognitive dysfunction rate

研究概览

简要总结

We frequently encounter cognitive impairments in patients over 65 undergoing Lower extremity surgery, depending on comorbidities and the choice of anesthesia method. The current development of neuraxial anesthesia techniques and close monitoring devices helps us prevent and detect cognitive impairment early in these patients. In this study, we aimed to investigate the effects of different anesthesia techniques (general anesthesia/spinal anesthesia) applied in orthopedic cases on patient fluid status (pleth variablity index) and regional cerebral oxygenation (NIRS), and their relationship with cognitive dysfunction.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients over the age of 65
  • Patients with an American Society of Anesthesiologists (ASA) score of II-III
  • Patients with a Mini Mental State Examination (MMSE) score of ≥24 on the first day before surgery

排除标准

  • Patients with coagulation disorders
  • Patients with a history of anticoagulant medication use
  • Patients with advanced organ failure
  • Patients with Alzheimer's disease or advanced dementia
  • Patients with allergies to the medications used in the study
  • Mental Retardation
  • Patients with a wound infection at the site of spinal anesthesia
  • Patients with a history of cerebrovascular hemorrhage
  • Patients who did not consent;

研究组 & 干预措施

General Anesthesia

Spinal anesthesia

结局指标

主要结局

Early postoperative period (24th and 48th hours) cognitive dysfunction rate

时间窗: Up to 48 hours after operation

We will assess postoperative cognitive dysfunction.Cognitive function will be evaluated using the MOCA (Montreal Cognitive Assessment) at 24 and 48 hours after surgery.

次要结局

  • Pleth Variability Index (PVI, %) to assess intraoperative fluid status(During Surgery)

研究者

发起方
Goztepe Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aygul Valiyeva

research assistant

Goztepe Training and Research Hospital

研究点 (2)

Loading locations...

相似试验