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临床试验/NCT05468996
NCT05468996已完成4 期

Median Effective Dose of Remimazolam for Sedation in Elderly Patients Undergoing Lower Limb Surgery Under Spinal Anesthesia

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月10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
60
试验地点
1
主要终点
success or failure of sedation maintenance

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. And 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 maintenance dose of remimazolam for sedation without mechanical ventilation has not been established. In addition, age might be an important factor for determining the appropriate dose of remimazolam.

In this study, we aim to identify the median effective dose of remimazolam for maintaining sedation in elderly patients undergoing lower limb surgery under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age: equal or older than 20 years
  • ASA PS: 1-3
  • patients who are scheduled to undergo lower limb surgery under spinal anesthesia with sedation using 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

young-old group

Active Comparator

a group of patients who are 60 to 74 years old

干预措施: Remimazolam (Drug)

old-old group

Active Comparator

a group of patients who are equal or older than 75 years

干预措施: Remimazolam (Drug)

young adult group

Active Comparator

a group of patients who are 20-59 years old

干预措施: Remimazolam (Drug)

结局指标

主要结局

success or failure of sedation maintenance

时间窗: throughout the surgery

MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

次要结局

  • respiratory depression(throughout the surgery)

研究者

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

Won Uk, Koh

Associate Professor

Asan Medical Center

研究点 (1)

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