Study to Determine if the Midazolam-Meperidine-Dexmedetomidine is Superior to the Midazolam-Meperidine for Sedation During ERCP (DEMMER)

This study has been completed.
Sponsor:
Collaborator:
Hana Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Sang Hyub Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01404689
First received: July 24, 2011
Last updated: July 13, 2013
Last verified: July 2013
  Purpose

Endoscopic retrograde cholangiopancreatography (ERCP) takes a longer time and is more complex to perform than the other parallel procedures, causing discomfort to patients. It is commonly performed under sedation endoscopy. Until recently, the combination administration of midazolam and opioid has been widely used as standard therapy due to its superior sedation effect compared to the other sedation agents. Midazolam, however, has problems, such as an insufficient sedation effect and an intermittent paradoxical response.

Unlike midazolam, propofol has no antagonist and may cause problems such as respiratory depression, and has a narrow therapeutic range for the sedation effect, consequently requiring supervision by experienced experts, although it has a better sedation effect than midazolam. Due to these disadvantages, propofol is clinically less useful than midazolam.

Meanwhile, dexmedetomidine, a selective α2 adrenergic agonist, is known to maintain the proper level of sedation and has a weak influence on respiratory depression. Recent studies have shown positive results with dexmedetomidine in relation with the sedation effect for surgery patients under local anesthesia or in intensive care units.

As such, extensive studies are being conducted on the use of dexmedetomidine in endoscopic procedures due to the increased attention to dexmedetomidine. This notwithstanding, the clinical usefulness of dexmedetomidine is still debatable. In particular, studies on the use of dexmedetomidine for ERCP are very rare.

Given the recent idea that dexmedetomidine may exert a synergistic effect in combination with midazolam, these authors endeavored to prospectively compare and analyze the sedation effect and adverse events, including respiratory depression, of the combination therapy of midazolam and meperidine, both of which have been widely used in patients undergoing ERCP, and of the combination therapy of midazolam, meperidine, and dexmedetomidine.

The small-scale comparative study on the combination administration of propofol and fentanyl, which has a high risk of causing complications, and on the single administration of dexmedetomidine is the only study on the sedation effect of dexmedetomidine in the ERCP procedure that has yet been conducted; there has been no study that investigated the effect of the combination administration of dexmedetomidine and other drugs in the ERCP procedure. This study is thus expected to contribute to the development of guidelines on sedation in the ERCP procedure.


Condition Intervention Phase
Undergoing ERCP for Diagnostic or Therapeutic Purposes
Drug: Dexmedetomidine
Other: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Midazolam With Meperidine and Dexmedetomidine vs Midazolam With Meperidine for Sedation During ERCP

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Level of sedation [ Time Frame: During entire procedure(ERCP) time; an expected average of the procedure time is 20 minutes ] [ Designated as safety issue: Yes ]
    The sedation level recorded by the RSS and the requirement of the additional sedative (midazolam) or the analgesic (meperidine), and the proportion (%) of cases where adequate sedation was maintained during entire procedure time.


Secondary Outcome Measures:
  • Complication rate [ Time Frame: From start point of the procedure(ERCP) to 60 minutes after the procedure ] [ Designated as safety issue: Yes ]
    • Change in respiration and hemodynamics

      • Mean blood pressure
      • Heart rate
      • Respiratory rate
      • Oxygen saturation
    • Adverse effects
    • The procedure and discharge time
    • Pain and patient satisfaction
    • Bispectral index scores


Enrollment: 110
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midazolam-Meperidine-Dexmedetomidine
midazolam 0.06mg/kg IV bolus, meperidine 50mg IV bolus and dexmedetomidine 1μg/Kg•hr infusion (30% reduction of midazolam dose and 25mg of meperidine for patients 65 years of age or older)
Drug: Dexmedetomidine
dexmedetomidine 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure
Other Name: Precedex® 100μg/1ml vial: DMDTIA
Sham Comparator: Midazolam-Meperidine
midazolam 0.06mg/kg IV bolus, meperidine 50mg IV bolus and placebo(saline) infusion(30% reduction of midazolam dose and 25mg of meperidine for patients 65 years of age or older)
Other: normal saline
0.9% NaCl 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure
Other Name: NaCl 0.9% 20ml plastic ample: NSIP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Those who are admitted for diagnostic and therapeutic ERCPs
  • aged 20 to 80 years
  • American Society of Anesthesiologists (ASA) classification I to III

Exclusion Criteria:

  • ASA physical status IV and V
  • allergic to any components of sedation and opioid drugs
  • patients with chronic illicit drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404689

Locations
Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Hana Pharmaceutical Co., Ltd
Investigators
Study Director: Sang Hyub Lee, M.D. Ph.D Assistant Professor of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital
Principal Investigator: Ban Seok Lee, M.D. Fellowship doctor, Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sang Hyub Lee, Assistant Professor of Internal Medicine, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01404689     History of Changes
Other Study ID Numbers: SNUBH-129-012
Study First Received: July 24, 2011
Last Updated: July 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
dexmedetomidine
midazolam
ERCP
cholangiopancreatography
sedation
propofol

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

ClinicalTrials.gov processed this record on September 30, 2014