NCT07674719尚未招募不适用
The Effect of Intraoperative Remimazolam Administration on the Incidence of Postoperative Acute Kidney Injury After Hepatobiliary and Pancreatic Surgery : a Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Acute kidney injury
研究概览
简要总结
We hypothesized that in patients undergoing elective hepatobiliary-pancreatic surgery, the group in which anesthesia is induced and maintained with remimazolam during surgery would maintain hemodynamic stability and reduce the incidence of postoperative acute kidney injury compared to propofol. The purpose is to provide practical evidence for perioperative management differentiated from other surgeries for hepatobiliary-pancreatic surgery patients for whom intraoperative fluid therapy is restricted.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 19 or older and under 85
- •Patients scheduled to undergo elective hepatopancreatic surgery under general anesthesia
- •American Society of Anesthesiologists (ASA) physical grade 1-3
- •Those who voluntarily consented to a written informed consent form prior to participation in the study
排除标准
- •Patients with hypersensitivity to other benzodiazepine drugs, including remimazolam, and to the components of this drug (e.g., patients with severe hypersensitivity to dextran 40)
- •Patients with hypersensitivity to propofol
- •Patients with underlying conditions: liver, neurological disorders, or acute narrow-angle glaucoma
- •Patients with severe or acute respiratory failure
- •Patients in shock or a coma
- •Patients taking TCA antidepressants
- •Patients with preoperative chronic kidney disease
研究组 & 干预措施
Remimazolam
Experimental
干预措施: Remimazolam (Byfavo) (Drug)
Propofol
Active Comparator
干预措施: propofol (Drug)
结局指标
主要结局
Acute kidney injury
时间窗: preop, postop day 0, 1, 3, 5
serum creatinine
次要结局
未报告次要终点
研究者
Park InSun
Assistant Professor
Seoul National University Bundang Hospital
研究点 (1)
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