The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Postoperative delirium
研究概览
简要总结
Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.
详细描述
After obtaining approval from the ethics committee, patients are recruited, informed of the trial process and potential risks, and their informed consent is obtained and signed. According to the WHO definition, patients are classified into smokers (defined as those who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day) and non-smokers (never smoked). Fecal and blood samples are collected from both groups of patients preoperatively, and perioperative data is gathered. Postoperatively, an uninformed observer assesses the patients for delirium and recovery quality.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >60 years;
- •American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;
- •Undergoing elective surgery;
- •Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.
排除标准
- •Mini-Mental State Examination (MMSE) score <23;
- •Preoperative biochemical tests indicate renal dysfunction or active liver disease;
- •History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;
- •History of alcohol abuse or drug dependency;
- •Taking antidepressant medications;
- •American Society of Anesthesiologists (ASA) preoperative anesthesia classification > Grade II.
结局指标
主要结局
Postoperative delirium
时间窗: Within 3 days post-surgery
CAM method
Quality of recovery in the first postoperative day
时间窗: Up to 24 hours after surgery.
Quality of recovery is assessed with the Quality of Recovery-15 questionaire in the first postoperative day.
次要结局
未报告次要终点
研究者
Chaochao Zhong
Principal Investigator
Affiliated Hospital of Nantong University