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临床试验/NCT03326960
NCT03326960Unknown不适用

Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators plan to perform the studies in 300 participants at Shanghai 10th People's Hospital.

详细描述

Postoperative delirium (POD) and postoperative cognitive disorder (POCD) are the most common complications of geriatric surgical patients, which could cause long-term social dysfunction, high mortality and increased medical cost. Currently, there is no efficient biomarker for POD/POCD, and it also remains largely unknown whether different anesthesia might lead to different incidence and severity of POD/POCD. The investigator's previous studies showed that thickness of retinal nerve fiber layer thickness (RNFL-T) measured by optical coherence tomography (OCT) was associated with POD/POCD; change of RNFL thickness (RNFL-C) in certain period correlated with cognitive deterioration. Thus, the investigators consider that RNFL might be a potential biomarker of POD/POCD. In the proposed large-scale longitudinal studies, the investigators will clinically validate RNF-LT as pre-operative POD/POCD biomarker, and RNFL-C as post-operative biomarker of POD/POCD. Finally, the investigators will compare the effects of surgery (total hip/knee replacement) under general anesthesia with sevoflurane, propofol and desflurane on the incidence and severity of POD/POCD in patients. Results from the proposed studies will likely establish RNFL as a potential POD/POCD biomarker, promote the clinical utilization of OCT-RNFL in early screening and outcome prediction of POD/POCD, and finally optimize anesthesia care of geriatric surgical patients to avoid or reduce POD/POCD incidence. These findings will lead to better postoperative outcomes of geriatric patients.

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

入选标准

  • 60 years old or older
  • Chinese Mandarin as the native language
  • scheduled to undergo hip/knee surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) class I-Ⅲ

排除标准

  • Prior diagnoses of neurological diseases according to ICD-10
  • History of severe psychiatric disorders according to DSM-IV
  • Visual or auditory defects
  • Participating in the investigation of another study

研究组 & 干预措施

Sevoflurane

Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.

干预措施: Sevoflurane (Drug)

Propofol

Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring.

干预措施: Propofol (Drug)

Desflurane

Patients in Desflurane group are maintained with desflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.

干预措施: Desflurane (Drug)

结局指标

主要结局

Postoperative delirium

时间窗: At 1st day after the surgery

Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day

次要结局

  • Postoperative delirium(At 3rd day after the surgery)
  • Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)(At 3rd day after the surgery)
  • Preoperative cognitive function(Preoperative cognitive function (baseline))
  • Postoperative cognitive dysfunction(Change from baseline cognitive dysfunction at 3rd month)
  • Retinal nerve fiber layer thickness(Change from baseline RNFL thickness at 3rd month)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan Shen, MD, PhD

Head of Psychiatry

Shanghai 10th People's Hospital

研究点 (1)

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