Endoscopic Retrograde CholangiopancreatographyPhase 4NCT01079312
Patient-controlled Sedation With Propofol and Remifentanyl for Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 4 study testing infusion pump, propofol and fentanyl in people with Endoscopic Retrograde Cholangiopancreatography, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- infusion pump, propofol and fentanyl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Apr 2009
- 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 70 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;
- ASA-class (American Society of Anaesthesiology) greater than 3;
- inability to co-operate;
- drugs abuse.
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: Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.
Read the detailed description
80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion pumpDevice
Also called -Braun AG, -an infusion pump
anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
infusion pump for patient-controlled sedationDevice
Also called -Arcomed,Syramed AG,Switzerland, -infusion pump designed for self administration of the drugs
self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.
propofolDrug
Also called -Diprivan, -Recofol, -Fresofol
Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.
fentanylDrug
Also called -fentanyl citrate, -fentanyl
Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.
sedative mixtureDrug
Also called -Ultiva, -Diprivan
Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
remifentanil hydrochloridDrug
Also called -Ultiva
Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
| Study group | Role | What they receive |
|---|---|---|
| Propofol infusion | Active comparator | Anaesthesiologist's managed intravenous infusion of propofol 10mg/ml Receives: Device: infusion pump; Drug: propofol; Drug: fentanyl |
| Patient-controlled sedation | Active comparator | self-administration of propofol and remifentanil mixture during ERCP Receives: Device: infusion pump for patient-controlled sedation; Drug: propofol; Drug: sedative mixture; Drug: remifentanil hydrochlorid |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol and opioid consumption
total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure
Measured: one day
vital signs
heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration
Measured: one day
patient´s and endoscopist´s satisfaction
Likert scale 1-7
Measured: one day
Secondary outcomes (1)
sedation level
sedation level assested with Ramsay,Gillham,OAA/S sedation scores
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 posted3 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies 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
- 80 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 SurgeryPekka Aho, MD, PhD, Principal investigator, Helsinki University Central Hospital,Department of Vascular SurgeryJorma Halttunen, Docent, Principal investigator, Helsinki University Central Hospital,Department of SurgeryMartti Färkilä, Professor, Principal investigator, Helsinki University Central Hospital,Department of GasroenterologyReino Pöyhiä, Docent, Study chair, Helsinki University Central Hospital,Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079312
- Sponsor's protocol ID
- a001c
- Other IDs
- 2008-007968-42, 2008
- Status last verified
- Dec 2020
- First submitted
- 1 Mar 2010
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Due to Finnish legal restriction patient data can not be accessed by others but the researches
Publications
Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.
PubMed 21295639
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Sedation vs Propofol Infusion for ERCP:a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01079312
- Acronym / sponsor ID
- a001c
- Keywords
- ERCP, patient-controlled sedation, propofol, remifentanil, sedation level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 3 Mar 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.
Background: Deep sedation with propofol and opioid is commonly used for endoscopic retrograde cholangiopancreatography (ERCP), but is associated with increased morbidity and mortality. Delivery of propofol and short-acting potent opioid analgesic using a self-administration device (patient-controlled sedation, PCS) could be another option for this purpose. Comparative studies with PCS for ERCP are lacking.The main objective of this prospective randomized trial trial was to compare PCS with propofol/remifentanil to anaesthesiologist managed propofol sedation during ERCP.
Detailed description
80 elective ERCP patients were randomized to anaesthesiologist managed propofol sedation (PI-group) or PCS with propofol/remifentanil (PCS-group). Sedation degree was estimated every 5 min throughout the procedure using Ramsay´s and Gillham´s sedation scores. Total amount of propofol was calculated at the end of procedure. Endoscopists´ and patients´ satisfaction was evaluated with questionary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol infusion | Active comparator | Device: infusion pump, Drug: propofol, Drug: fentanylAnaesthesiologist's managed intravenous infusion of propofol 10mg/ml |
| Patient-controlled sedation | Active comparator | Device: infusion pump for patient-controlled sedation, Drug: propofol, Drug: sedative mixture, Drug: remifentanil hydrochloridself-administration of propofol and remifentanil mixture during ERCP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective ERCP-patients
Key exclusion criteria (4 listed)
- allergy to propofol or opioid;
- ASA-class (American Society of Anaesthesiology) greater than 3;
- inability to co-operate;
- drugs abuse.
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 |
|---|---|---|
| infusion pumpAlso: -Braun AG, -an infusion pumpanaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level | Device | Propofol infusion |
| infusion pump for patient-controlled sedationAlso: -Arcomed,Syramed AG,Switzerland, -infusion pump designed for self administration of the drugsself-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump. | Device | Patient-controlled sedation |
| propofolAlso: -Diprivan, -Recofol, -FresofolPropofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture. | Drug | Patient-controlled sedation, Propofol infusion |
| fentanylAlso: -fentanyl citrate, -fentanylFentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated. | Drug | Propofol infusion |
| sedative mixtureAlso: -Ultiva, -DiprivanSedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml) | Drug | Patient-controlled sedation |
| remifentanil hydrochloridAlso: -UltivaSolution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details) | Drug | Patient-controlled sedation |
Primary outcome
propofol and opioid consumption
Time frame: one day
total consumption of propofol,milligramms and opioid,microgramms during ERCP procedure
vital signs
Time frame: one day
heart rate,blood pressure,peripheral oxygen saturatuion,breathing rate,expiratory carbon dioxide concentration
patient´s and endoscopist´s satisfaction
Time frame: one day
Likert scale 1-7
1 secondary outcome
sedation level
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 22 Dec 2020.
- Results publication: PubMed 21295639Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.
- Individual participant dataSharing planned: No. Due to Finnish legal restriction patient data can not be accessed by others but the researches
Related trials for Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Not yet recruiting
XRAIconnect Image Guidance Software for ERCP Procedures
Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
Recruiting
Efficacy and Safety of Anricofen Combined With Ciprofol for Deep Sedation in Elderly Patients Undergoing ERCP
Anesthesia, Sedation
Not yet recruiting
Rectal Indomethacin With or Without Papillary Ice Water Irrigation to Prevent Post-ERCP Pancreatitis
Pancreatitis
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 infusion pump, propofol and fentanyl in people with Endoscopic Retrograde Cholangiopancreatography, 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 4 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 22 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?
propofol and opioid consumption (time frame: one day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079312, which also lists 1 linked publication.
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 22 Dec 2020.