Exploring the Use of Remimazolam (BYFAVO®) in Patients at High Risk for ERCP to Reduce Intraoperative Hypotension and Assess Safety and Efficacy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- the duration and severity of hypotension checklist
研究概览
简要总结
We conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ERCP) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.
详细描述
Remimazolam is a novel ultra-short-acting benzodiazepine-like anesthetic used for gastrointestinal endoscopic procedures, characterized by predictable sedation duration and rapid recovery. Propofol, commonly used in clinical practice as an intravenous anesthetic, also exhibits rapid onset, short duration, and quick recovery characteristics. To date, there is relatively limited literature comparing the likelihood of intraoperative hypotension during general anesthesia with these two agents in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Additionally, a comparison is needed regarding the frequency of additional sedative doses required during anesthesia induction and the occurrence of major postoperative complications, including pancreatitis.
Therefore, the investigators we conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk ERCP could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications. The investigators aimed to enroll 60 patients with a 1:1 ratio of ASA III to IV undergoing ERCP. The investigators anticipate that Remimazolam can reduce intraoperative hypotension, acute postoperative pancreatitis, and the occurrence of major organ complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged between 20 and 90 years old;
- •ASA (American Society of Anesthesiologists) class III to IV;
- •Body Mass Index (BMI) between 18 and 30 kg/m².
排除标准
- •Uncontrolled hypertension or hypotension, or clinically significant coronary artery atherosclerosis heart disease or heart failure;
- •Severe respiratory system disorders;
- •Severe sinus bradycardia, heart conduction block, frequent ventricular arrhythmias, or atrial fibrillation;
- •Clinically significant coagulation disorders;
- •End-stage liver failure or kidney disease requiring dialysis;
- •Emergency surgery;
- •Peripheral artery disease with upper limb functional impairment;
- •Other conditions deemed inappropriate by the investigator, including patients with superficial pharyngeal cancer for whom rapid extubation is not suitable during ERCP.
研究组 & 干预措施
patients receiving Remimazolam
干预措施: Remimazolam (Drug)
patients without Remimazolam
干预措施: placebo (Drug)
结局指标
主要结局
the duration and severity of hypotension checklist
时间窗: 1 day (during the ERCP examination)
during the ERCP examination
次要结局
未报告次要终点
研究者
National Taiwan University Clinical Trial Center
Research Ethic Committee D
National Taiwan University Hospital