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临床试验/NCT04983966
NCT04983966已完成不适用

Comparison of Quality of Recovery (QoR)-15 Scores According to the Anesthetics (Desflurane vs. Remimazolam) in the Patients With Lumbar Fusion Surgery: a Prospective Double-blind Randomized Controlled Trial

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年8月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
The difference of QoR-15 scores

研究概览

简要总结

The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the lumbar fusion surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who aged 20-70 years with ASA-PS 1-3, BMI <30 undergoing lumbar fusion surgery under general anesthesia

排除标准

  • Tolerance or hypersensitivity to benzodiazepine or propofol
  • Dependence or addiction to psychotropic drugs or alcohol
  • Pregnant women
  • subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

研究组 & 干预措施

Desflurane group

Experimental

General anesthesia with volatile agent of desflurane

干预措施: Desflurane (Drug)

Remimazolam group

Active Comparator

Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.

干预措施: Remimazolam (Drug)

结局指标

主要结局

The difference of QoR-15 scores

时间窗: postoperative day 1

The difference of scores in the Quality of Recovery (QoR)-15 survey between desflurane group and remimazolam group. 0 (minimum), 150 (maximum): Higher scores means better.

次要结局

未报告次要终点

研究者

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

Myoung Hwa Kim

Associate Professor

Gangnam Severance Hospital

研究点 (1)

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