NCT02475824

A Randomized Comparison of Midazolam With Meperidine and Dexmedetomidine Versus Midazolam With Meperidine and Propofol for Sedation During ERCP

Completed Phase 4 Last updated 4 April 2018

What this trial tests

Phase 4 trial testing Midazolam® in Complication in 258 participants. Completed in 30 January 2017.

Timeline

1 May 2015

Primary endpoint
30 November 2016

30 January 2017

Quick facts

Lead sponsor	Dankook University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	258
Start date	1 May 2015
Primary completion	30 November 2016
Estimated completion	30 January 2017
Sites	1 location across South Korea

Drugs / interventions tested

• Midazolam®
• "Meperidine" (pethidine®) — full drug profile →
• Propofol®
• Dexmedetomidine (Precedex®) — full drug profile →

Conditions studied

• Complication — all drugs for Complication →

Sponsor

Dankook University

Who can join

Adults 18 to 80, any sex, with Complication. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• the rates of cardiopulmonary complications
  Time frame: From start point of the procedure(ERCP) to 60 minutes after the procedure
  respiratory depression (≤10 breaths/min); desaturation (SaO2\<90% with no recovery against a verbal stimulus or jaw extension); hypotension (systolic blood pressure \<90mmHg or 20% reduction from baseline mean blood pressure

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.