Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- The incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing selective craniotomy.
- •Age ≥65 years.
- •Obtain written informed consent.
排除标准
- •Operation time less than 2 hours.
- •Refusal to provide written informed consent.
- •Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
- •Allergic to the study drug.
- •Body mass index ≤18 or ≥ 30 kg/m
- •History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
- •History of traumatic brain injury or neurosurgery.
- •Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
- •Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
- •The functional neurosurgery.
研究组 & 干预措施
DEX group
The DEX group patients will be received dexmedetomidine intraoperatively.
干预措施: Dexmedetomidine (Drug)
Placebo group
The placebo group patients will be received 0.9% saline intraoperatively.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
The incidence of postoperative delirium
时间窗: postoperative 5 day
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
次要结局
- Pain severity score(postoperative 5 day)
- The quality of recovery(postoperative 1 day)
- The quality of sleep(postoperative 3 day)
- Cognitive function(1 day before surgery and 5 days after surgery)
- Psychological health state(1 day before surgery and postoperative 5 day)
- The intraoperative data(The surgery day)
- Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.(postoperative 5 day)
- 30-day all-cause mortality(postoperative 30 day)
- The physiological status(1 day before surgery)
- Electroencephalogram changes(The surgery day)
- Regional cerebral oxygen saturation changes(The surgery day)
研究者
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital