Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

NCT01070680 | Completed Phase 4

• 2 other identifiers: a004c2009-014862-25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis

Keywords

ERCP; dexmedetomidine; propofol; patient-controlled sedation; Chronic Alcoholic pancreatitis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

sedative medicine

Drug: Precedex

sodium chloride 0,9%

PLACEBO COMPARATOR

Drug: sodium chlorid 0,9%

Interventions

Precedex DRUG

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

Also known as: dexmedetomidine hydrochloride injection

dexmedetomidine

sodium chlorid 0,9% DRUG

continuous intravenous infusion

Also known as: NaCl 0,9%

sodium chloride 0,9%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective ERCP-patients with chronic alcohol pancreatitis

You may not qualify if:

• Allergy to the dexmedetomidine, propofol or any opioid, ASA(American Society of Anaesthesiology)class grater when 3

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Maxim Mazanikov, MD

  Helsinki University Central Hospital,Department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

• Marianne Udd, MD,PhD

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Outi Lindström, MD

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Leena Kylänpää, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Jorma Halttunen, Docent

  Helsinki University Central Hospital,Department of Surgery

  PRINCIPAL INVESTIGATOR

• Martti Färkkilä, Professor

  Helsinki University Central Hospital,Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

• Reino Pöyhiä, Docent

  Helsinki University Central Hospital,Department of Anaesthesiology

  STUDY DIRECTOR

• Harri Mustonen, PhD

  Department of Gastrointestinal and General Surgery, Helsinki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

FI (1)