Comparison of Postoperative Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics (Propofol vs. Remimazolam) During Total Intravenous Anesthesia in the Spine Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- The difference of QoR-15 scores between two groups (propofol vs. remimazolam)
研究概览
简要总结
Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. In addition, it has no injection pain and infusion syndrome compared with propofol. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. Therefore, rhe purpose of the study is to compare poetoperative quality of recovery (QoR)-15 scores according to the use of anesthetics for total intravenous anesthesia in the cervical spine surgery with intraoperative neurophysiological monitoring.
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
- 是
入选标准
- •Adult patients who aged 20-70 years with ASA-PS 1-3,
- •diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy
- •intraoperative neurophysiological monitoring.
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
Propofol group
Propofol based total intravenous anesthesia
干预措施: Propfol group (Drug)
Remimazolam group
Remimazolam based total intravenous anesthesia
干预措施: Remimazolam group (Drug)
结局指标
主要结局
The difference of QoR-15 scores between two groups (propofol vs. remimazolam)
时间窗: postoperative day 1
The difference of scores in the Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores means better.
次要结局
未报告次要终点
研究者
Dong Woo Han
Professor
Gangnam Severance Hospital