drugset / Trial / NCT01920113
A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
RandomizedParallel-groupSingle-blindTreatment
Summary
Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-01
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.3 ug/kg | — |
| Subject | Dexmedetomidine | Other / unclassified | 0.7 ug/kg | — |
| Comparator | Propofol | Small molecule | 3 mg/kg | — |
| Comparator | Propofol | Small molecule | 5 mg/kg | — |
| Comparator | Remifentanil | Small molecule | 6 ug/kg | — |