Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Pancreatitis Clinical Trial

Official title:

Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070680
• Other study ID #: a004c
• Secondary ID: 2009-014862-25
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2010
• Last updated: July 13, 2012
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Drug:
• Precedex
mkg/ml,continuous infusion at rate 0.7 µg/kg/h
• sodium chlorid 0,9%
continuous intravenous infusion

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedation degree		1 day	No
Primary	propofol consumption		1 day	No
Primary	endoscopist´s and patient´s satisfaction		1 day	No
Primary	vital signs:blood pressure, oxygen saturation, heart rate, breathing rate		1 day	No