drugset / Trial / NCT05305248
Sedation With Remimazolam During Spinal Anesthesia
RandomizedParallel-groupDouble-blindPrevention
Summary
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.
Timeline
- Start
- 2022-04-19
- Primary completion
- 2022-09-15
- Completion
- 2022-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 0.2 ug/kg | Intravenous |
| Comparator | Dexmedetomidine | Other / unclassified | 0.7 ug/kg | Intravenous |
| Subject | Remimazolam | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | Remimazolam | Small molecule | 1 mg/kg | Intravenous |
Indications
No indication recorded.