NCT05801757已完成不适用
Sedative Effect of Remidazolam Besylate Continuous Pump Infusion for Colonoscopic Polypectomy in Elderly Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Sedation success rate
研究概览
简要总结
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.
详细描述
To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Single blind
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-80 years old;
- •ASA Level I - III;
- •Operation time: 15min~1h;
- •BMI18.0-29.9；
排除标准
- •Emergency surgery;
- •Patients with high risk of gastric satiety and reflux aspiration;
- •Allergies to benzodiazepines and opioids;
- •Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
- •Abnormal liver and kidney function;
- •Previous drug use history;
- •Recently participated in other clinical studies;
- •Patients who cannot cooperate with communication.
研究组 & 干预措施
Propofol group
Active Comparator
propofol 2-3mg/kg/h
干预措施: Propofol (Drug)
R1 group
Experimental
remimazolam 0.5mg/kg/h
干预措施: Remimazolam (Drug)
R2 group
Experimental
remimazolam 0.75mg/kg/h
干预措施: Remimazolam (Drug)
结局指标
主要结局
Sedation success rate
时间窗: 1 day
Evaluating the success rate of sedation using the modified MOAA/S scoring table
次要结局
- Intraoperative time record(Intraoperative)
- Drug usage(1 day)
- The incidence of adverse reactions during surgery(1 day)
- Incidence of postoperative adverse reactions(24 hours after surgery)
研究者
研究点 (1)
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