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Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Primary Purpose

Pancreatitis

Status

Completed

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Precedex

sodium chlorid 0,9%

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring ERCP, dexmedetomidine, propofol, patient-controlled sedation, Chronic Alcoholic pancreatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dexmedetomidine

sodium chloride 0,9%

Arm Description

sedative medicine

Outcomes

Primary Outcome Measures

sedation degree

propofol consumption

endoscopist´s and patient´s satisfaction

vital signs:blood pressure, oxygen saturation, heart rate, breathing rate

Secondary Outcome Measures

Full Information

NCT ID

NCT01070680

First Posted

February 17, 2010

Last Updated

July 13, 2012

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01070680

Brief Title

Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation

Official Title

Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine

Arm Type

Active Comparator

Arm Description

sedative medicine

Arm Title

sodium chloride 0,9%

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Precedex

Other Intervention Name(s)

dexmedetomidine hydrochloride injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sodium chlorid 0,9%

Other Intervention Name(s)

NaCl 0,9%

Intervention Description

continuous intravenous infusion

Primary Outcome Measure Information:

Title

sedation degree

Time Frame

1 day

Title

propofol consumption

Time Frame

1 day

Title

endoscopist´s and patient´s satisfaction

Time Frame

1 day

Title

vital signs:blood pressure, oxygen saturation, heart rate, breathing rate

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: