SedationPhase 4NCT01072435
Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 4 study of Sedation, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sedation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2010to Nov 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective ERCP patients
Who cannot join
- allergy to propofol or opioid;
- inability to cooperate;
- ASA(American Society of Anaesthesiology)class greater than 3
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit
Helsinki, Uusimaa, 00029
About this study
Official title: Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).
Read the detailed description
80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .
- Conditions
- Sedation
- Being tested
- Patient-controlled sedation, Target-controlled infusion
- Keywords
- ERCP, patient-controlled sedation, target-controlled infusion, propofol, Sedation with propofol for ERCP, Endoscopic Retrograde Cholangiopancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled sedationDevice
Also called Arcomed/Syramed AG infusion pump designed for self administration of medicines
Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.
Target-controlled infusionDevice
Also called Arcomed/Syramed AG target-controlled infusion device.
Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol
| Study group | Role | What they receive |
|---|---|---|
| patient-controlled sedation | Active comparator | PCS Receives: Device: Patient-controlled sedation |
| target-controlled infusion | Active comparator | TCI Receives: Device: Target-controlled infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation degrees
Measured: One day
patient's and endoscopist´s satisfaction,
Measured: One day
propofol consumption
Measured: One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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
- None (open label)
- Enrolment
- 82 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, Helsiki University Central Hospital,Department of AnaesthesiologyMarianne Udd, MD.,PhD, Principal investigator, Helsinki University Central Hospital,Department of SurgeryLeena Kylänpää, Docent, Principal investigator, Helsinki University Central Hospital,Department of SurgeryOuti Lindström, MD, Principal investigator, Helsinki University Central Hospital,Department of SurgeryJorma Halttunen, Docent, Principal investigator, Helsinki University Central Hospital,Department of SurgeryMartti Färkilä, Professor, Principal investigator, Helsinki University Central Hospital,Department of GastroenterologyReino Pöyhiä, Docent, Study chair, Helsinki University Central Hospital,Department of AnaesthesiologyHarri Mustonen, PhD, Principal investigator, Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072435
- Sponsor's protocol ID
- a005c
- Other IDs
- 2009-015564-34, 2009
- Status last verified
- Dec 2020
- First submitted
- 19 Feb 2010
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01072435
- Acronym / sponsor ID
- a005c
- Conditions
- Sedation
- Keywords
- ERCP, patient-controlled sedation, target-controlled infusion, propofol, Sedation with propofol for ERCP, Endoscopic Retrograde Cholangiopancreatography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 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.
Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).
Detailed description
80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-controlled sedation | Active comparator | Device: Patient-controlled sedationPCS |
| target-controlled infusion | Active comparator | Device: Target-controlled infusionTCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective ERCP patients
Key exclusion criteria (3 listed)
- allergy to propofol or opioid;
- inability to cooperate;
- ASA(American Society of Anaesthesiology)class greater than 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 |
|---|---|---|
| Patient-controlled sedationAlso: Arcomed/Syramed AG infusion pump designed for self administration of medicinesAdministration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit. | Device | patient-controlled sedation |
| Target-controlled infusionAlso: Arcomed/Syramed AG target-controlled infusion device.Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol | Device | target-controlled infusion |
Primary outcome
sedation degrees
Time frame: One day
patient's and endoscopist´s satisfaction,
Time frame: One day
propofol consumption
Time frame: One day
vital signs:oxygen saturation,blood pressure,heart rate,breathing rate
Time frame: One 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 7 Dec 2020.
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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
Helsiki University Central Hospital,Department of Anaesthesiology
Marianne Udd, MD.,PhD principal investigator
Helsinki University Central Hospital,Department of Surgery
Leena Kylänpää, Docent 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 of Sedation, 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 3 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 7 Dec 2020. 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. 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 degrees (time frame: One 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 7 Dec 2020.