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Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maxim Mazanikov, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01070680
First received: February 17, 2010
Last updated: July 13, 2012
Last verified: July 2012
History of Changes

February 17, 2010
July 13, 2012
March 2010
January 2011   (final data collection date for primary outcome measure)
  • sedation degree [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • propofol consumption [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • endoscopist´s and patient´s satisfaction [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • vital signs:blood pressure, oxygen saturation, heart rate, breathing rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
sedation degree,propofol consumption,endoscopist´s and patient´s satisfaction,vital signs:blood pressure,oxygen saturation,heart rate,breathing rate. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070680 on ClinicalTrials.gov Archive Site
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Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation
Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pancreatitis
  • Drug: Precedex
    mkg/ml,continuous infusion at rate 0.7 µg/kg/h
    Other Name: dexmedetomidine hydrochloride injection
  • Drug: sodium chlorid 0,9%
    continuous intravenous infusion
    Other Name: NaCl 0,9%
  • Active Comparator: dexmedetomidine
    sedative medicine
    Intervention: Drug: Precedex
  • Placebo Comparator: sodium chloride 0,9%
    Intervention: Drug: sodium chlorid 0,9%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01070680
a004c, 2009-014862-25
No
Maxim Mazanikov, Helsinki University Central Hospital
Helsinki University Central Hospital
Not Provided
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
Helsinki University Central Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP