Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing robot-assisted pancreaticoduodenectomy.
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective robotic-assisted pancreaticoduodenectomy were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 over 65 years old
- •Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
- •Written informed consent was obtained.
排除标准
- •Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
- •Patients with history of psychiatric or neurological disorders.
- •Patients with body mass index ≤ 18 or ≥ 30
- •Pregnant or lactating women
- •Patients with severe bradycardia (heart rate less than 40 beats per minute)
- •Patients with pathological sinus node syndrome or grade 2 or greater AV block
- •Patients with severe hepatic or renal insufficiency.
- •Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
研究组 & 干预措施
Placebo group
Use 250 ml of saline as placebo group.
干预措施: Saline (Other)
Experimental group
Use dexmedetomidine as experimental group
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Participants will be followed for the duration of hospital stay, an expected average of 5 days.Evaluations are conducted twice a day.
次要结局
未报告次要终点
研究者
Hao Li
Associate professor
Chinese PLA General Hospital