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临床试验/NCT03393676
NCT03393676Unknown不适用

Preoperative Chronic Pain Increases the Risk of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: a Prospective Observational Cohort Study

RenJi Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
POCD incidence 7 days (or before leaving hospital) after surgery

研究概览

简要总结

The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

详细描述

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.

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

入选标准

  • Elder than 65 years old
  • Speak Chinese Mandarin
  • Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
  • Signed the inform consent
  • American Society of Anesthesiologists classification I to II

排除标准

  • Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
  • Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
  • Severe hearing or visual impairment
  • Unwillingness to comply with the protocol or procedures
  • Cannot communicate with Chinese Mandarin
  • Serious pulmonary, heart , liver or renal insufficiency patients
  • Had anesthesia or surgery within the past 30 days

结局指标

主要结局

POCD incidence 7 days (or before leaving hospital) after surgery

时间窗: 7 days (or before leaving hospital)

POCD incidence 7 days (or before leaving hospital) after surgery

次要结局

  • POCD incidence 2 months after surgery(2 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaorong Huai

Dr.

RenJi Hospital

研究点 (2)

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