Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Pancreatitis

Treatments: Drug: Precedex; Drug: sodium chlorid 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01070680

a004c

2009-014862-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

dexmedetomidine

Active Comparator group

Description:

sedative medicine

Treatment:

Drug: Precedex

sodium chloride 0,9%

Placebo Comparator group

Treatment:

Drug: sodium chlorid 0,9%