Biliary Tract DiseasesPhase 4NCT01350037
Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 4 study testing alfentanil and remifentanil in people with Biliary Tract Diseases and Pancreatic Diseases, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- alfentanil and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2009to Sep 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 analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.
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: Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study
Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.
Read the detailed description
Deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.Careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.Self-administration of propofol by the patient him- or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep sedation the main advantages of PCS are reduced consumption of anesthetics and faster recovery.A combination of propofol and different opioids is widely used for PCS however, it is not known which opioid would be the most suitable one. Remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. The elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. The investigators also sought information about frequency of sedation related complications associated with the different opioids.
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- alfentanil, remifentanil
- Keywords
- patient-controlled sedation, propofol, alfentanil, remifentanil, endoscopic retrograde cholangiopancreatography
- Medical subject headings
- Biliary Tract Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfentanilDrug
Also called Rapifen, Alfenta
Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.
remifentanilDrug
Also called Ultiva
Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.
| Study group | Role | What they receive |
|---|---|---|
| remifentanil | Active comparator | sedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml Receives: Drug: remifentanil |
| alfentanil 0.04 mg/ml | Active comparator | sedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml Receives: Drug: alfentanil |
| alfentanil 0.08 mg/ml | Active comparator | sedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml Receives: Drug: alfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of propofol and opioid
Measured: one day
vital signs
Heart rate (HR), electrocardiogram (ECG), breathing rate, peripheral oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) constant monitoring. Noninvasive blood pressure (NIBP)measuring at 5 min intervals.
Measured: one day
Secondary outcomes (4)
sedation levels
Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score
Measured: one day
pain intensity
Numeric range scale
Measured: one day
patient´s and endoscopist´s satisfaction with sedation
Measured: one day
incidence of nausea
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 posted9 May 2011 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 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
- Reino Pöyhiä, MD,PhD, Study director, Helsinki University Central Hospital, Department of Anesthesiology and Intensive CareMaxim Mazanikov, MD, Principal investigator, Helsinki University Central Hospital,Department of Anesthesiology and Intensive CareMartti Färkkilä, MD,Professor, Principal investigator, Helsinki University Central Hospital,Department of Medicine, Division of GastroenterologyLeena Kylänpää, MD,PhD, Principal investigator, Helsinki University Central Hospital,Department of Gastrointestinal and General SurgeryJorma Halttunen, MD,PhD, Principal investigator, Helsinki University Central Hospital,Department of Gastrointestinal and General SurgeryOuti Lindström, MD,PhD, Principal investigator, Helsinki University Central Hospital,Department of Gastrointestinal and General SurgeryHarri Mustonen, DSc, Principal investigator, Helsinki University Central Hospital, Department of SurgeryMarianne Udd, MD,PhD, Principal investigator, Helsinki University Central Hospital,Department of Gastrointestinal and General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350037
- Sponsor's protocol ID
- a002c
- Other IDs
- 2009-012398-36, 2009
- Status last verified
- Jul 2012
- First submitted
- 5 May 2011
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfentanil vs Remifentanil in Patient-controlled Sedation During ERCP.A Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT01350037
- Acronym / sponsor ID
- a002c
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- patient-controlled sedation, propofol, alfentanil, remifentanil, endoscopic retrograde cholangiopancreatography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 9 May 2011 (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.
Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.
Detailed description
Deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.Careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.Self-administration of propofol by the patient him- or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep sedation the main advantages of PCS are reduced consumption of anesthetics and faster recovery.A combination of propofol and different opioids is widely used for PCS however, it is not known which opioid would be the most suitable one. Remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. The elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. The investigators also sought information about frequency of sedation related complications associated with the different opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| remifentanil | Active comparator | Drug: remifentanilsedative mixture for PCS consisting of propofol 10mg/ml 20 ml and remifentanil 50 mkg/ml 5 ml |
| alfentanil 0.04 mg/ml | Active comparator | Drug: alfentanilsedative mixture for PCS consisting of propofol10 mg/ml 20 ml,alfentanil 0.5 mg/ml 2 ml, NaCL 9 mg/ml 3 ml |
| alfentanil 0.08 mg/ml | Active comparator | Drug: alfentanilsedative mixture for PCS consisting of propofol 10 mg/ml 20 ml, alfentanil 0.5 mg/ml 4 ml,NaCl 9mg/ml 1ml |
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 (1 listed)
- allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.
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 |
|---|---|---|
| alfentanilAlso: Rapifen, AlfentaAlfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage. | Drug | alfentanil 0.04 mg/ml, alfentanil 0.08 mg/ml |
| remifentanilAlso: UltivaRemifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min. | Drug | remifentanil |
Primary outcome
consumption of propofol and opioid
Time frame: one day
vital signs
Time frame: one day
Heart rate (HR), electrocardiogram (ECG), breathing rate, peripheral oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) constant monitoring. Noninvasive blood pressure (NIBP)measuring at 5 min intervals.
4 secondary outcomes
sedation levels
Time frame: one day
pain intensity
Time frame: one day
patient´s and endoscopist´s satisfaction with sedation
Time frame: one day
incidence of nausea
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 6 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.
Reino Pöyhiä, MD,PhD study director
Helsinki University Central Hospital, Department of Anesthesiology and Intensive Care
Maxim Mazanikov, MD principal investigator
Helsinki University Central Hospital,Department of Anesthesiology and Intensive Care
Martti Färkkilä, MD,Professor principal investigator
Helsinki University Central Hospital,Department of Medicine, Division of Gastroenterology
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 alfentanil and remifentanil in people with Biliary Tract Diseases and Pancreatic Diseases, 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 6 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. 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?
consumption of propofol and opioid (time frame: one day). The study lists 2 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 6 Jul 2012.