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临床试验/NCT06497283
NCT06497283招募中不适用

The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2024年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Intraoperative remifentanil dose

研究概览

简要总结

It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Patients scheduled for general anesthesia
  • Patients aged 20-60
  • Patients with American Society of Anesthesiologist physical status classification 1-2
  • Patients with ideal body weight 50-80 kg

排除标准

  • Patients with hearing disability
  • Patients using opioids or sedatives in 1 week
  • Patients who are dependent for alcoholics or drugs
  • Patients with hypersensitivities to remimazolam or remifentanil
  • Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
  • Patients with liver failure

结局指标

主要结局

Intraoperative remifentanil dose

时间窗: At anesthesia day 0

Intraoperative remifentanil dose will be measured at anesthesia day 0.

次要结局

  • Intraoperative remimazolam dose(At anesthesia day 0)
  • Electroencephalography(At anesthesia day 0)
  • Pain score (0:no pain, 10:maximal pain)(At anesthesia day 0 and 1)

研究者

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

Hyun-Chang Kim

Associate Professor

Gangnam Severance Hospital

研究点 (2)

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