Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- The incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.
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 undergoing selective frontotemporal tumor resection.
- •Age ≥18 years.
- •Obtain written informed consent.
排除标准
- •Refusal to provide written informed consent.
- •Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
- •Allergic to the study drug.
- •History of psychotropic drugs within past 30 days.
- •Pregnant or lactating women.
- •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 hepatic or renal dysfunction.
研究组 & 干预措施
DEX group
The DEX group will receives dexmedetomidine intraoperative.
干预措施: Dexmedetomidine (Drug)
Placebo group
The placebo group will receives 0.9% saline intraoperative.
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
- Quality of recovery from surgery(1 day after surgery)
- Intraoperative cardiovascular event.(From the study drug infusion to the end of surgery.)
- Pain score(within 5 days after surgery)
- Sleep quality(within 3 days after surgery)
研究者
Yuming Peng
Deputy chief of Department of Anethesiology
Beijing Tiantan Hospital