Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During General Anesthesia in the Cervical Spine Surgery Patients: Sevoflurane vs. Remimazolam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The difference between two groups (sevoflurane vs. remimazolam) in 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 cervical spine 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 the investigators study is that, in patients with cervical spine surgery, total intravenous anesthesia based on remimazolam can improve the the quality of recovery compared to inhalation anesthesia based on sevoflurane.
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
- •ASA-PS: 1-3
- •BMI < 30
- •Anterior cervical discectomy and fusion surgery
排除标准
- •Tolerance or hypersensitivity to benzodiazepine
- •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
Arm 1) Sevoflurane group
Sevoflurane based inhalation anesthesia
干预措施: Sevoflurane based inhalation anesthesia (Drug)
Arm 2) Remimazolam group
Remimazolam based total intravenous anesthesia
干预措施: Remimazolam based total intravenous anesthesia (Drug)
结局指标
主要结局
The difference between two groups (sevoflurane vs. remimazolam) in QoR-15 scores
时间窗: postoperative day 1
The difference of scores in the Quality of Recovery (QoR)-15 survey on POD 1 Total 0-150, 0 (minimum), 150 (maximum), Higher scores means better.
次要结局
未报告次要终点
研究者
Myoung Hwa Kim
Associate Professor
Gangnam Severance Hospital