PancreatitisPhase 4NCT01070680
Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation
A Phase 4 study testing Precedex and sodium chlorid 0,9% in people with Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Precedex and sodium chlorid 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective ERCP-patients with chronic alcohol pancreatitis
Who cannot join
- Allergy to the dexmedetomidine, propofol or any opioid, ASA(American Society of Anaesthesiology)class grater when 3
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital,Meilahti hospital,Endoscopy unit
Helsinki, Uusimaa, 00029
About this study
Official title: Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study
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
- Being tested
- Precedex, sodium chlorid 0,9%
- Keywords
- ERCP, dexmedetomidine, propofol, patient-controlled sedation, Chronic Alcoholic pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Also called dexmedetomidine hydrochloride injection
mkg/ml,continuous infusion at rate 0.7 µg/kg/h
sodium chlorid 0,9%Drug
Also called NaCl 0,9%
continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | sedative medicine Receives: Drug: Precedex |
| sodium chloride 0,9% | Placebo comparator | Not described Receives: Drug: sodium chlorid 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation degree
Measured: 1 day
propofol consumption
Measured: 1 day
endoscopist´s and patient´s satisfaction
Measured: 1 day
vital signs:blood pressure, oxygen saturation, heart rate, breathing rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxim Mazanikov, Helsinki University Central Hospital
- Investigators
- Maxim Mazanikov, MD, Principal investigator, Helsinki University Central Hospital,Department of AnaesthesiologyMarianne Udd, MD,PhD, Principal investigator, Helsinki University Central Hospital,Department of SurgeryOuti Lindström, MD, Principal investigator, Helsinki University Central Hospital,Department of SurgeryLeena Kylänpää, Docent, Principal investigator, Helsinki University Central Hospital,Department of SurgeryJorma Halttunen, Docent, Principal investigator, Helsinki University Central Hospital,Department of SurgeryMartti Färkkilä, Professor, Principal investigator, Helsinki University Central Hospital,Department of GastroenterologyReino Pöyhiä, Docent, Study director, Helsinki University Central Hospital,Department of AnaesthesiologyHarri Mustonen, PhD, Principal investigator, Department of Gastrointestinal and General Surgery, Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070680
- Sponsor's protocol ID
- a004c
- Other IDs
- 2009-014862-25, 2009
- Status last verified
- Jul 2012
- First submitted
- 17 Feb 2010
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine vs Placebo in ERCP Sedation.A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01070680
- Acronym / sponsor ID
- a004c
- Conditions
- Pancreatitis
- Keywords
- ERCP, dexmedetomidine, propofol, patient-controlled sedation, Chronic Alcoholic pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Precedexsedative medicine |
| sodium chloride 0,9% | Placebo comparator | Drug: sodium chlorid 0,9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective ERCP-patients with chronic alcohol pancreatitis
Key exclusion criteria (1 listed)
- Allergy to the dexmedetomidine, propofol or any opioid, ASA(American Society of Anaesthesiology)class grater when 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrecedexAlso: dexmedetomidine hydrochloride injectionmkg/ml,continuous infusion at rate 0.7 µg/kg/h | Drug | dexmedetomidine |
| sodium chlorid 0,9%Also: NaCl 0,9%continuous intravenous infusion | Drug | sodium chloride 0,9% |
Primary outcome
sedation degree
Time frame: 1 day
propofol consumption
Time frame: 1 day
endoscopist´s and patient´s satisfaction
Time frame: 1 day
vital signs:blood pressure, oxygen saturation, heart rate, breathing rate
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxim Mazanikov, MD principal investigator
Helsinki University Central Hospital,Department of Anaesthesiology
Marianne Udd, MD,PhD principal investigator
Helsinki University Central Hospital,Department of Surgery
Outi Lindström, MD principal investigator
Helsinki University Central Hospital,Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precedex and sodium chlorid 0,9% in people with Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedation degree (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.