Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

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.

Conditions

• Pancreatitis

Interventions

DRUG

Precedex

mkg/ml,continuous infusion at rate 0.7 µg/kg/h

DRUG

sodium chlorid 0,9%

continuous intravenous infusion

Sponsors & Collaborators

• Helsinki University Central Hospital

  lead OTHER

Principal Investigators

• Maxim Mazanikov, MD · Helsinki University Central Hospital,Department of Anaesthesiology

• Marianne Udd, MD,PhD · Helsinki University Central Hospital,Department of Surgery

• Outi Lindström, MD · Helsinki University Central Hospital,Department of Surgery

• Leena Kylänpää, Docent · Helsinki University Central Hospital,Department of Surgery

• Jorma Halttunen, Docent · Helsinki University Central Hospital,Department of Surgery

• Martti Färkkilä, Professor · Helsinki University Central Hospital,Department of Gastroenterology

• Reino Pöyhiä, Docent · Helsinki University Central Hospital,Department of Anaesthesiology

• Harri Mustonen, PhD · Department of Gastrointestinal and General Surgery, Helsinki

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2011-01-31

Completion

2011-01-31

Countries

• Finland

Study Locations