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临床试验/NCT05694091
NCT05694091招募中不适用

Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年11月18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
46
试验地点
1
主要终点
3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale

研究概览

简要总结

In view of the increasingly severe aging situation in China, the perioperative brain health of elderly patients has received increasing attention. Postoperative delirium (POD) is a common postoperative complication characterized by acute consciousness and cognitive dysfunction. The incidence of POD in elderly patients undergoing elective non cardiac surgery is 20%~45%, which often indicates poor cognitive recovery and becomes a heavy burden for family and society. Although the weight of human brain only accounts for 2% of body weight, the oxygen consumption accounts for 20% of the total oxygen consumption of the whole body. On July 2, 2022, the British Journal of Anaesthesia (Chinese Academy of Sciences Division 1, Anesthesiology Division 1, IF11.719), the top international Journal in the field of anesthesiology, published the scientific research achievements of the first author of the applicant. It was found for the first time that sevoflurane, the most commonly used inhalation anesthetic in clinical practice, can cause the activation of glycolysis and the increase of lactic acid in the brain of elderly non-human primate marmosets, which suggests that general anesthetics will affect brain metabolism in the perioperative period. Therefore, we hypothesized that perioperative changes in brain metabolism might be related to the occurrence of POD in elderly patients. The purpose of this study was to study the relationship between the changes of brain metabolites and POD during perioperative period by noninvasive monitoring of the characteristics of brain tissue metabolites 24 hours before and 24 hours after the operation with hydrogen ion proton magnetic resonance spectroscopy (1-HMRS). In order to complete this purpose, this study plans to collect subjects aged 65~90 years who are scheduled to undergo oral and maxillofacial surgery under general anesthesia. The changes of brain metabolites before and after operation were collected by 1-HMRS, and the postoperative delirium related scale was evaluated to analyze the relationship between perioperative changes of brain metabolites and POD.

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 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The ASA grade of the subject is Ⅰ - Ⅲ;
  • •65-90 years old;
  • •Oral craniomaxillofacial surgery under combined general anesthesia

排除标准

  • •The following medical devices have been installed in the body or are to be installed or implanted in the hospital: various cardiac pacemakers; Metal implants (non titanium), ferromagnetic vascular clips in the body
  • •The patient is left-handed;
  • •Patients with claustrophobia;
  • •People with vision and hearing impairment, illiterate or difficult to communicate;
  • •The operation plan includes patients with tracheotomy or postoperative catheterization;
  • •Refusing to sign the clinical trial consent form.

结局指标

主要结局

3D-CAM (3-minute Diagnostic Interview for Confusion Assessment Method) scale

时间窗: 7 day after surgery

3D-CAM higher means worse

次要结局

  • MOCA(Montreal Cognitive Assessment) scale(7 day after surgery)
  • MMSE (mini-mental state examiniation) scale(7 day after surgery)

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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