drugset / Trial / NCT02475824

Midazolam With Meperidine and Dexmedetomidine vs. Midazolam With Meperidine and Propofol for Sedation During ERCP

NCT02475824

Phase 4 Completed 258 enrolled Dankook University
RandomizedParallel-groupDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
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.