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Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

NCT ID: NCT01070680

Last Updated: 2012-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Pancreatitis

Keywords

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ERCP dexmedetomidine propofol patient-controlled sedation Chronic Alcoholic pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine

sedative medicine

Group Type ACTIVE_COMPARATOR

Precedex

Intervention Type DRUG

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

sodium chloride 0,9%

Group Type PLACEBO_COMPARATOR

sodium chlorid 0,9%

Intervention Type DRUG

continuous intravenous infusion

Interventions

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Precedex

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

Intervention Type DRUG

sodium chlorid 0,9%

continuous intravenous infusion

Intervention Type DRUG

Other Intervention Names

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dexmedetomidine hydrochloride injection NaCl 0,9%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maxim Mazanikov

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maxim Mazanikov, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Anaesthesiology

Marianne Udd, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Outi Lindström, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Leena Kylänpää, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Jorma Halttunen, Docent

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Surgery

Martti Färkkilä, Professor

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital,Department of Gastroenterology

Reino Pöyhiä, Docent

Role: STUDY_DIRECTOR

Helsinki University Central Hospital,Department of Anaesthesiology

Harri Mustonen, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastrointestinal and General Surgery, Helsinki

Locations

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Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-014862-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

a004c

Identifier Type: -

Identifier Source: org_study_id