Clinical trial NCT01070680: Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation
Official title: Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Keywords: ERCP
dexmedetomidine
propofol
patient-controlled sedation
Chronic Alcoholic pancreatitis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: sedation degree
timeFrame: 1 day
measure: propofol consumption
timeFrame: 1 day
measure: endoscopist´s and patient´s satisfaction
timeFrame: 1 day
measure: vital signs:blood pressure, oxygen saturation, heart rate, breathing rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
name: Maxim Mazanikov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Marianne Udd, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Outi Lindström, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Leena Kylänpää, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Surgery
name: Jorma Halttunen, Docent
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Gastroenterology
name: Martti Färkkilä, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital,Department of Anaesthesiology
name: Reino Pöyhiä, Docent
role: STUDY_DIRECTOR
affiliation: Department of Gastrointestinal and General Surgery, Helsinki
name: Harri Mustonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: