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Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070680
First Posted: February 18, 2010
Last Update Posted: July 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
  Purpose

In this pilot prospective non-commercial clinical trial the investigators will study the use of dexmedetomidine as an adjuvant to the patient-controlled propofol sedation in a placebo-controlled and randomized manner in patients with drug addiction during Endoscopic Retrograde Cholangiopancreatography (ERCP). Dexmedetomidine is a sedative medication used mostly in intensive care units,and is marketed under the brand name Precedex. Dexmedetomidine has sedative, analgesic, sympatholytic, and anxiolytic properties. It produces sedation without causing significant respiratory depression. Recent research has suggested dexmedetomidine to be effective in treatment of alcohol withdrawal signs. In previous studies dexmedetomidine was insufficient as an only sedative agent in ERCP and colonoscopy, but it has not been assessed for sedation in patients with chronic pancreatitis. The main objective of this trial is to evaluate if dexmedetomidine can reduce propofol and opioid consumption and facilitate the performance of ERCP in patients with chronic pancreatitis due to drug addiction.Secondary objectives of the trial are the stability of vital signs and safety, patients´ satisfaction plus recovery time from sedation.

50 elective ERCP patients with chronic pancreatitis after written informed consent and randomisation will be recruited to the study. Exclusion criteria are:allergy to propofol, opioid or dexmedetomidine, ASA class greater than 3. All the patients will receive patient-controlled propofol sedation. In dexmedetomidine group dexmedetomidine infusion will be started before sedation beginning and in placebo group placebo-solution (NaCl0,9%) will be administered in the similar manner.Standard monitoring for vital signs will be applied,also sedation degrees will be evaluated with sedation scores. At the end of procedure total amount of propofol and opioid will be calculated,patients and endoscopists satisfaction and the difficulty of ERCP will be assessed.


Condition Intervention Phase
Pancreatitis Drug: Precedex Drug: sodium chlorid 0,9% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by Maxim Mazanikov, Helsinki University Central Hospital:

Primary Outcome Measures:
  • sedation degree [ Time Frame: 1 day ]
  • propofol consumption [ Time Frame: 1 day ]
  • endoscopist´s and patient´s satisfaction [ Time Frame: 1 day ]
  • vital signs:blood pressure, oxygen saturation, heart rate, breathing rate [ Time Frame: 1 day ]

Enrollment: 50
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexmedetomidine
sedative medicine
Drug: Precedex
mkg/ml,continuous infusion at rate 0.7 µg/kg/h
Other Name: dexmedetomidine hydrochloride injection
Placebo Comparator: sodium chloride 0,9% Drug: sodium chlorid 0,9%
continuous intravenous infusion
Other Name: NaCl 0,9%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective ERCP-patients with chronic alcohol pancreatitis

Exclusion Criteria:

  • Allergy to the dexmedetomidine, propofol or any opioid, ASA(American Society of Anaesthesiology)class grater when 3
  Contacts and Locations
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): NCT01070680


Locations
Finland
Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit
Helsinki, Uusimaa, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Maxim Mazanikov, MD Helsinki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Marianne Udd, MD,PhD Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Outi Lindström, MD Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Leena Kylänpää, Docent Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Jorma Halttunen, Docent Helsinki University Central Hospital,Department of Surgery
Principal Investigator: Martti Färkkilä, Professor Helsinki University Central Hospital,Department of Gastroenterology
Study Director: Reino Pöyhiä, Docent Helsinki University Central Hospital,Department of Anaesthesiology
Principal Investigator: Harri Mustonen, PhD Department of Gastrointestinal and General Surgery, Helsinki
  More Information

Responsible Party: Maxim Mazanikov, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01070680     History of Changes
Other Study ID Numbers: a004c
2009-014862-25 ( EudraCT Number )
First Submitted: February 17, 2010
First Posted: February 18, 2010
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Maxim Mazanikov, Helsinki University Central Hospital:
ERCP
dexmedetomidine
propofol
patient-controlled sedation
Chronic Alcoholic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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