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临床试验/NCT05340335
NCT05340335已完成4 期

Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月18日最近更新:
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
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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hajung Kim

Clinical Assistant Professor

Asan Medical Center

研究点 (1)

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