Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- the incidence of delirium postoperatively
研究概览
简要总结
Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium
详细描述
The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with temporal glioma scheduled for a elective craniotomy
- •Age ≥18 years
- •Obtain written informed consent.
排除标准
- •Patients with severe preoperative cognitive impairment
- •History of traumatic brain injury or previous neurosurgery
- •History of psychotropic medications
- •Allergy to dexmedetomidine
- •Pregnant or lactating women
- •History of obstructive sleep apnoea syndrome
- •Severe bradycardia(heart rate <40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block
- •Severe hepatic dysfunction
- •Severe renal dysfunction
研究组 & 干预措施
Dex group
Subjects assigned to Dex group will receive a continuous dexmedetomidine infusion (0.4 ug/kg/h) after anesthesia induction until dural closure, and then received an intravenous analgesia pump with dexmedetomidine(0.08ug/kg/h), sufentanil and antiemetic until 48 hours postoperatively
干预措施: Dexmedetomidine (Drug)
Placebo group
Subjects in the Placebo group were given comparable volumes of normal saline during the surgery, and intravenous analgesia pump also contains sufentanil and antiemetic, but no dexmedetomidine used until 48 hours postoperatively.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the incidence of delirium postoperatively
时间窗: the postoperative 5 days
Using the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessment,combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments will be only conducted in patients with RASS sedation score exceeding -4.The CAM-ICU and the 3D-CAM describes four main characteristics of delirium: acute altered mental state ,fluctuating level of consciousness, inattention, and confusion of thought. If both the first and second features are present, and both the third or fourth features are present, the patient is diagnosed with postoperative delirium.
次要结局
- the intensity of pain(the postoperative 5 days)
- the quality of sleep(the postoperative 5 days)
- the severity of postoperative delirium(the postoperative 5 days)
- safety outcomes(from the start of medicine infusion to 48 hours postoperatively)
研究者
Yuming Peng
Clinical Professor
Beijing Tiantan Hospital