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

NCT02475824 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-04-06

No results posted yet for this study

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.

Conditions

  • Complication

Interventions

DRUG

Midazolam®

midazolam (0.05 mg/kg, 30% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea)

DRUG

"Meperidine" (pethidine®)

Meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea).

DRUG

Propofol®

Repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation.

DRUG

Dexmedetomidine (Precedex®)

Dexmedetomidine (1μg/kg/h, Precedex; Hospira, Seoul, Republic of Korea) or the same volume of normal saline were administered in the MMD and midazolam-meperidine group

Sponsors & Collaborators

  • Dankook University

    lead OTHER

Principal Investigators

  • Jun Ho Choi, MD · Dankook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-11-30
Completion
2017-01-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475824 on ClinicalTrials.gov