The Second Affiliated Hospital of Nanchang University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The goal of this observational study is to compare Incidence of postoperative delirium in Sarcopenic and non-sarcopenic elderly patients undergoing gastrointestinal surgery. The main question it aims to answer are:
• Effect of preoperative sarcopenia on postoperative delirium in elderly patients undergoing gastrointestinal surgery Participants will be evaluated preoperatively for sarcopenia and assessed for postoperative delirium, pain, etc.
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
- 否
入选标准
- •Age ≥ 65 years old, gender is not limited
- •Patients to undergo elective abdominal surgery (gastrointestinal tumor resection) under general anesthesia, with an expected operation duration of about 2h~4h
排除标准
- •Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications
- •Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN
- •People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment
- •Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack
- •Myasthenia gravis patients
- •Unable to cooperate to complete the test, the patient or family member rejected the participant
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.
Postoperative delirium was assessed using the 3D-CAM scale. It consists of 4 features, and a positive feature 1 and 2 plus 3 or 4 is considered postoperative delirium.
次要结局
- Diastolic pressure(Up to 5 hours in the operating room)
- Postoperative pain(Within 7 days after surgery)
- Minimum postoperative albumin(Up to 1 month after surgery)
- Systolic pressure(Up to 5 hours in the operating room)
- Mean pressure(Up to 5 hours in the operating room)
- Complication(During the perioperative period, up to 1 month after surgery)
- Length of stay in ICU(Up to 1 month after surgery)
- Maximum postoperative C-reactive protein (CRP)(Up to 1 month after surgery)
- Heart rate(Up to 5 hours in the operating room)
- Incidence of postoperative admission to ICU(Up to 1 month after surgery)
- Length of hospitalization(After the patient is discharged from the hospital, average 1 month)
研究者
Fuzhou Hua
Chief Physician
Second Affiliated Hospital of Nanchang University