Whether Opioids Are Factor That Induced Postoperative Delirium?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .
详细描述
Postoperative delirium (POD) is a common postoperative complication of the elderly caused by a variety of factors. POD is an acute neuropsychiatric disorder characterized by disturbance of attention consciousness and cognitive function fluctuation, and more than 40% of elderly patients have symptoms of hypoactivity POD.The incidence of POD is as high as 17% to 61% in patients with neurocognitive impairment and patients undergoing complex or emergency surgery, which usually occurs between 1 and 3 days after surgery. POD will lead to prolonged hospital stay, functional impairment and even death. How to prevent and treat POD is an urgent clinical problem to be solved at present.
Opiates are commonly used perioperative sedatives and analgesics, which may be associated with the occurrence of postoperative POD in elderly patients and increase the risk of POD. It is not clear whether perioperative use of low doses of opioids could reduces the incidence of POD in elderly patients. In this study, reducing-opioids anesthesia was defined as the use of 1/3 of the conventional opioid dose to observe whether reducing-opioids anesthesia affected the incidence of POD in elderly patients undergoing gastric cancer surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
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
- •Patients' age ≥65 years
- •Underwent elective radical gastrectomy
排除标准
- •Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
- •Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
- •History of alcohol abuse or a history of drug dependence
- •Have brain surgery or trauma
- •Cannot with the completion of tests of Postoperative Cognitive Dysfunction
- •Refused to participate in the study
研究组 & 干预措施
Sufentanyl+Epidural analgesia
Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
干预措施: Sufentanil Citrate (Drug)
Sufentanyl+Epidural analgesia
Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
Sufentanyl+Epidural analgesia
Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
干预措施: Epidural catheter (Procedure)
Epidural analgesia
Only use of ropivacaine for intraoperative and postoperative analgesia
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
Epidural analgesia
Only use of ropivacaine for intraoperative and postoperative analgesia
干预措施: Epidural catheter (Procedure)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 3 days after surgery
Richmond agitation and sedation scale(RASS), the RASS score was divided into 10 sedation scales, ranging from +4 to -5, representing the patient's degree from "aggressive" to "unconscious," with each score corresponding to a state of consciousness. When the RASS score was ≥-3, the CAM-ICU assessment was performed.
次要结局
- Anaesthesia related adverse event(3 days after surgery)
- Visual analogue scale(VAS)(3 days after surgery)
- blood pressure(3 days after surgery)
研究者
Fang Jun
Director
Zhejiang Cancer Hospital