NCT05651399已完成4 期
Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Frequency of hypotension during surgery (1hour)
研究概览
简要总结
The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-3
- •Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam
排除标准
- •Patients who refuse to participate in this study
- •Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
- •Patients with an allergy to propofol, fentanyl, or bupivacaine
- •Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
- •Patients judged to be inappropriate for this study
研究组 & 干预措施
Remimazolam
Active Comparator
A maintenance dose of remimazolam is administered for sedation
干预措施: Remimazolam (Drug)
Propofol
Active Comparator
A maintenance dose of propofol is administered for sedation
干预措施: Propofol (Drug)
结局指标
主要结局
Frequency of hypotension during surgery (1hour)
时间窗: up to 1 hour after initiation of drug infusion
mean blood pressure less than 65mmHg
次要结局
- Frequency of hypotension during surgery(Throughout the surgery)
- Total administered phenylephrine(Throughout the surgery)
- Fluid volume(Throughout the surgery)
- Number of hypotensive episodes in the post-anesthesia care unit after surgery(up to 1 hour after postanesthesia care unit entry)
- Complications after surgery(up to 7 days after surgery)
研究者
Hajung Kim
Clinical assistant professor
Asan Medical Center
研究点 (1)
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