Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Phase 4

Completed

• Conditions: Pancreatitis
• Interventions: Drug: Precedex; Drug: sodium chlorid 0,9%

• Registration Number: NCT01070680
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-13
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Precedex	sedative medicine
sodium chloride 0,9%	sodium chlorid 0,9%	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit; 🇫🇮 Helsinki, Uusimaa, Finland