Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Study Overview
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Brief Summary
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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.

Official Title
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Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study

Conditions
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Pancreatitis

Intervention / Treatment
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* Drug: Precedex
* Drug: sodium chlorid 0,9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine<br>sedative medicine | Drug: Precedex<br>* mkg/ml,continuous infusion at rate 0.7 µg/kg/h<br>* Other names: dexmedetomidine hydrochloride injection;|
| Placebo Comparator: sodium chloride 0,9%<br> | Drug: sodium chlorid 0,9%<br>* continuous intravenous infusion<br>* Other names: NaCl 0,9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation degree |  | 1 day | 
| propofol consumption |  | 1 day | 
| endoscopist´s and patient´s satisfaction |  | 1 day | 
| vital signs:blood pressure, oxygen saturation, heart rate, breathing rate |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, dexmedetomidine, propofol, patient-controlled sedation, Chronic Alcoholic pancreatitis