Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation
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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 |
- 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 |
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| Finland | |
| Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit | |
| Helsinki, Uusimaa, Finland, 00029 | |
| 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 May 21, 2013