Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- MOAA/S score
研究概览
简要总结
Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe cardiovascular or respiratory disease
- •Contraindication to spinal anesthesia
- •Heart block
- •Previous hepatectomy or liver transplant
- •Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- •Estimated glomerular filtration rate < 30 mL/min/1.73m2
- •Acute narrow angle glaucoma
- •Myasthesia gravis
- •Known allergy to the drugs included in the study
排除标准
- •Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
研究组 & 干预措施
Remimazolam group
Sedation with remimazolam during spinal anesthesia
干预措施: Remimazolam (Drug)
Dexmedetomidine group
Sedation with dexmedetomidine during spinal anesthesia
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
MOAA/S score
时间窗: up to 30 minutes after PACU arrival
MOAA/S score will be evaluated by an 5-point scale from iniation of sedative drugs to 30 minutes after PCAU arrival at 10 minutes intervals.
次要结局
- Sedation induction time Sedation induction time(up to 5 minutes after initation of sedative drugs)
- Differences in basic vital signs between the two groups(Baseline)
研究者
Do-Hyeong Kim
Professor
Gangnam Severance Hospital