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

NCT02475824 | Completed Phase 4 DMC

• 1 other identifier: DankookU
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ERCP; Sedation; safety

Outcome Measures

Primary Outcomes (1)

• the rates of cardiopulmonary complications

  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

  From start point of the procedure(ERCP) to 60 minutes after the procedure

Secondary Outcomes (3)

• Sedation efficacy

  From start point of the procedure(ERCP) to 1 hour after the procedure

• procedural satisfaction

  From start point of the procedure(ERCP) to 1 day after the procedure

• Speed of recovery

  From start point of the procedure(ERCP) to 1 hour after the procedure

Study Arms (2)

MMD arm

EXPERIMENTAL

Both midazolam® (0.05 mg/kg, 30% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea) and meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea) are given intravenously at the initiation of sedation. In addition, a continuous IV infusion of dexmedetomidine (1ug/kg/h, Precedex; Hospira, Seoul, Republic of Korea) is administered 15 min before the ERCP till complete procedure

Drug: Midazolam®; Drug: "Meperidine" (pethidine®); Drug: Dexmedetomidine (Precedex®)

BPS arm

ACTIVE COMPARATOR

IV bolus dose of midazolam® (0.06mg/kg, 50% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea) and meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea). Repeated doses of 10-20 mg propofol® are titrated to achieve the target level of sedation. 0.9% NaCl 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure

Drug: Midazolam®; Drug: "Meperidine" (pethidine®); Drug: Propofol®

Interventions

Midazolam® DRUG

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

Also known as: Midazolam

BPS arm; MMD arm

"Meperidine" (pethidine®) DRUG

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

Also known as: meperidine

BPS arm; MMD arm

Propofol® DRUG

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

Also known as: Propofol

BPS arm

Dexmedetomidine (Precedex®) DRUG

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

Also known as: Dexmedetomidine

MMD arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are scheduled for ERCPs
• aged 18 to 80 years
• American Society of Anesthesiologists (ASA) classification I to III

You may not qualify if:

• ASA IV and V
• History of allergies to drug used
• refuse to participate the study

Sponsors & Collaborators

• Dankook University: lead

Study Sites (1)

Dankook University College of Medicine

Cheonan, Chungcheongnam-do, 330-715, South Korea

Location

MeSH Terms

Interventions

Midazolam; Meperidine; Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles

Study Officials

• Jun Ho Choi, MD

  Dankook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 14, 2015
• First Posted: June 19, 2015
• Study Start: May 1, 2015
• Primary Completion: November 30, 2016
• Study Completion: January 30, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

KR (1)