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

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ClinicalTrials.gov Identifier: NCT02475824
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Ho Choi, Dankook University

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.


Condition or disease Intervention/treatment Phase
Complication Drug: Midazolam® Drug: "Meperidine" (pethidine®) Drug: Propofol® Drug: Dexmedetomidine (Precedex®) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Midazolam With Meperidine and Dexmedetomidine Versus Midazolam With Meperidine and Propofol for Sedation During ERCP
Study Start Date : May 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : January 30, 2017


Arm Intervention/treatment
Experimental: MMD arm
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®
midazolam (0.05 mg/kg, 30% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea)
Other Name: Midazolam

Drug: "Meperidine" (pethidine®)
Meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea).
Other Name: meperidine

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
Other Name: Dexmedetomidine

Active Comparator: BPS arm
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®
midazolam (0.05 mg/kg, 30% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea)
Other Name: Midazolam

Drug: "Meperidine" (pethidine®)
Meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea).
Other Name: meperidine

Drug: Propofol®
Repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation.
Other Name: Propofol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sedation efficacy [ Time Frame: From start point of the procedure(ERCP) to 1 hour after the procedure ]
    Modified Observe's Assessment of Alertness and Sedation: 5-responds readily to name spoken in normal tone, 4-lethargic response to name spoken in normal tone, 3-responds only after name is called loudly and/or repeatedly, 2-responds only after mild prodding or shaking, 1-does not respond to mild prodding or shaking, 0-does not respond to noxious stimulus.

  2. procedural satisfaction [ Time Frame: From start point of the procedure(ERCP) to 1 day after the procedure ]
    respective visual analog scale (VAS; 0=no pain/ no satisfaction, 10=worst pain imaginable/full satisfaction

  3. Speed of recovery [ Time Frame: From start point of the procedure(ERCP) to 1 hour after the procedure ]
    speed of recovery (modified Aldrete score) are recorded at 5-minute intervals until discharge from the recovery room



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475824


Locations
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Korea, Republic of
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Sponsors and Collaborators
Dankook University
Investigators
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Principal Investigator: Jun Ho Choi, MD Dankook University

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Responsible Party: Jun Ho Choi, Assistant professor, Dankook University
ClinicalTrials.gov Identifier: NCT02475824     History of Changes
Other Study ID Numbers: DankookU
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Jun Ho Choi, Dankook University:
ERCP
Sedation
safety

Additional relevant MeSH terms:
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Propofol
Dexmedetomidine
Midazolam
Meperidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Analgesics, Opioid
Narcotics