NCT07036419
招募中
2 期
A Clinical Study on Efficacy and Safety of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The overall sedation success rate.
概览
简要总结
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent.
- •Subjects requiring elective general anesthesia surgery.
- •Male or female.
- •Meet the weight standard.
排除标准
- •Pediatric patients scheduled for elective cardiothoracic, neurosurgical, or hepatic surgery.
- •Patients who are planned to receive any anesthetic techniques other than total intravenous anesthesia (TIVA) from entry into the operating room until the end of surgery, such as inhalational anesthesia, epidural anesthesia, or spinal anesthesia.
- •Patients with a medical history or clinical evidence that may increase the risk of sedation or anesthesia and are deemed unsuitable for participation by the investigator.
- •Patients with a history of asthma or with risk for difficult mask ventilation or difficult intubation by the investigator's judgment.
- •With clinically significant abnormal clinical laboratory test value.
- •Known intolerance or allergy to benzodiazepines, propofol, opioids, neuromuscular blocking agents, or any of their components.
研究组 & 干预措施
Remimazolam Group
Experimental
干预措施: Remimazolam Tosilate for injection (Drug)
Propofol Group
Active Comparator
干预措施: Propofol Injection (Drug)
结局指标
主要结局
The overall sedation success rate.
时间窗: Throughout the anesthesia procedure.
The overall sedation success rate, which encompasses both successful induction of sedation and successful maintenance of adequate sedation throughout the anesthesia procedure.
次要结局
- Proportion of subjects with hemodynamic instability.(Up to 2 days.)
- Incidence and severity of adverse events during the study.(Up to 3 days.)
研究者
研究点 (1)
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