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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Maxim Mazanikov, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01070680     History of Changes
Other Study ID Numbers: a004c, 2009-014862-25
Study First Received: February 17, 2010
Last Updated: July 13, 2012
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 26, 2014