Midazolam With Meperidine and Dexmedetomidine vs. Midazolam With Meperidine and Propofol for Sedation During ERCP
Summary
This is a single-center, prospective, randomized, double-blinded study of consecutive patients referred for ERCP. A recent study suggested that the addition of dexmedetomidine to the midazolam-meperidine regimen (MMD)provided better sedative efficacy and a superior safety profile during ERCP compared with a midazolam-meperidine regimen. Further study is warranted to compare an MMD regimen with propofol-based regimen. Randomization is performed by use of a computer-generated random allocations in a ratio of 1:1 in balanced blocks of 4. A separate sedating nurse, who don't participate in the study, is the only person with knowledge of the sedation regimen. This separate nurse repeated the injection of propofol and completed questionnaires.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-11-30
- Completion
- 2017-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 1 ug/kg | Intravenous |
| Subject | Midazolam | Small molecule | 0.05 mg/kg | Intravenous |
| Subject | Midazolam | Small molecule | 0.06 mg/kg | Intravenous |
| Subject | Midazolam | Small molecule | 1 mg | Intravenous |
| Subject | Midazolam | Small molecule | 2 mg | Intravenous |
| Comparator | Propofol | Small molecule | 5 mg | — |
| Comparator | Propofol | Small molecule | 10 mg | — |
| Comparator | Propofol | Small molecule | 20 mg | — |
| Background | Meperidine | Unknown | 25 mg | Intravenous |
| Background | Meperidine | Unknown | 50 mg | Intravenous |
Indications
No indication recorded.