Endoscopic Retrograde CholangiopancreatographyNCT01840371
Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing Conventional sedation and Experimental sedation in people with Endoscopic Retrograde Cholangiopancreatography, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- Conventional sedation and Experimental sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Mar 2014
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who scheduled for ERCP
Who cannot join
- The patients with ASA physical classification V
- The patients with history of sulfite, egg or soy bean allergy
- The patients during pregnancy or latency period
- The patients who informed consent could not be obtained
- The patients who were under 20 years old
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University
Seoul, Seoul, 120-752
About this study
The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.
- Being tested
- Conventional sedation, Experimental sedation
- Keywords
- ERCP, Sedation, Fentanyl, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional sedationDrug
Propofol Meperidine : 25 mg IV just before procedure
- IV bolus of 1 mg/kg for sedation induction,
- Infusion of 60 mcg/min/kg for maintenance of sedation
- Additional bolus dose of 10mg as needed for adequate sedation
Experimental sedationDrug
Fentanyl
- IV bolus of 1 µg/kg for sedation induction
- Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol
- IV bolus of 0.4 mg/kg for sedation induction
- Infusion of 30 µg/min/kg for maintenance of sedation
- Additional bolus dose of 10mg as needed for adequate depth of sedation
| Study group | Role | What they receive |
|---|---|---|
| Propofol based group | Experimental | Not described Receives: Drug: Conventional sedation |
| Fentanyl based group | Active comparator | Not described Receives: Drug: Experimental sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Recovery time (time from scope withdrawal to full recovery)
Measured: time from scope withdrawal to full recovery at averange 24 hours
Secondary outcomes (1)
Adverse event during and after procedure
Adverse event during and after procedure i. Desaturation rate ii. Apnea
Measured: measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Yonsei UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840371
- Sponsor's protocol ID
- 4-2013-0012
- Status last verified
- Jun 2014
- First submitted
- 22 Apr 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.
PubMed 22615018Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.
PubMed 22873637
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study for Analyzing Clinical Benefit of Pain Focused Sedation With Combination of Fentanyl and Propofol During Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT01840371
- Acronym / sponsor ID
- 4-2013-0012
- Keywords
- ERCP, Sedation, Fentanyl, Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Apr 2013 (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.
The investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during Endoscopic retrograde cholangiopancreatography (ERCP). The investigators will assess recovery time and adverse effect during ERCP as the primary end point between two group. The investigators will also access satisfaction score for endoscopist and patients as the secondary end point.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol based group | Experimental | Drug: Conventional sedation |
| Fentanyl based group | Active comparator | Drug: Experimental sedation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who scheduled for ERCP
Key exclusion criteria (5 listed)
- The patients with ASA physical classification V
- The patients with history of sulfite, egg or soy bean allergy
- The patients during pregnancy or latency period
- The patients who informed consent could not be obtained
- The patients who were under 20 years old
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 |
|---|---|---|
| Conventional sedationPropofol Meperidine : 25 mg IV just before procedure * IV bolus of 1 mg/kg for sedation induction, * Infusion of 60 mcg/min/kg for maintenance of sedation * Additional bolus dose of 10mg as needed for adequate sedation | Drug | Propofol based group |
| Experimental sedationFentanyl * IV bolus of 1 µg/kg for sedation induction * Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol * IV bolus of 0.4 mg/kg for sedation induction * Infusion of 30 µg/min/kg for maintenance of sedation * Additional bolus dose of 10mg as needed for adequate depth of sedation | Drug | Fentanyl based group |
Primary outcome
Recovery time
Time frame: time from scope withdrawal to full recovery at averange 24 hours
Recovery time (time from scope withdrawal to full recovery)
1 secondary outcome
Adverse event during and after procedure
Time frame: measurements of recovery time during ERCP procedure & after ERCP procedure at average 24 hours
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 4 Jun 2014.
- Results publication: PubMed 22615018Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.
- Results publication: PubMed 22873637Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional sedation and Experimental sedation in people with Endoscopic Retrograde Cholangiopancreatography, run by Yonsei University at 1 site in South Korea.
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 5 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 4 Jun 2014. 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 South Korea. 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.
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?
Recovery time (time frame: time from scope withdrawal to full recovery at averange 24 hours). 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 NCT01840371, which also lists 2 linked publications.
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 4 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.