Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Whether sedation was successful
研究概览
简要总结
Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. nd through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.
In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA PS 1-3
- •Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam
排除标准
- •Patients who refuse to participate in this study
- •Patients with hypersensitivity to benzodiazepine or flumazenil
- •Patients with severe renal/hepatic disease
- •Patients with drug/alcohol abuse
- •Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
- •Patients with difficulty in communication
- •Patients with severe obstructive sleep apnea or other airway problems
- •Patients contraindicated to regional anesthesia
- •Patients judged to be inappropriate for this study
研究组 & 干预措施
Remimazolam
A loading dose of remimazolam is administered for sedation
干预措施: Remimazolam (Drug)
结局指标
主要结局
Whether sedation was successful
时间窗: for 10 minutes from the initiation of the remimazolam administration
MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
次要结局
- Total amount of remimazolam for sedation(From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes)
- Effect site concentration(From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes)
研究者
Hajung Kim
Clinical Assistant Professor
Asan Medical Center
