Hepatobiiliary Diseases Requiring Endoscopic Retrograde CholangiopancreatographyNCT06359834
Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography
A study testing Remimazolam besylate and Propofol in people with Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography, run by Yonsei University at 1 site in South Korea.
Trial summary
Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- Remimazolam besylate and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2024to 29 Aug 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age 19~80 yrs, ASA Class I~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph
Who cannot join
- Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr >2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP <90mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
Seoul, 120-752
About this study
Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.
- Being tested
- Remimazolam besylate, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. Remimazolam 2mg is added in case of inadequate sedation.
PropofolDrug
Patients in this group receives 1mg/kg of propofol to induce sedation prior to endoscope insertion. Propofol 20mg is added in case of inadequate sedation.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Patient group who receives remimazolam for sedation during endoscopy Receives: Drug: Remimazolam besylate |
| Propofol | Active comparator | Patient group who receives propofol for sedation during endoscopy Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.
Measured: Evaluation begins after sedative administration until the end of endoscopic procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start11 Apr 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
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 Hepatobiiliary Diseases Requiring 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 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
- NCT06359834
- Sponsor's protocol ID
- 4-2023-1693
- Status last verified
- Sep 2024
- First submitted
- 7 Apr 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Lee K, Lee SJ, Leem G, Lee HS, Park JY, Bang S, Park SW, Kim N, Chung MJ. Remimazolam Preserves Oxygen Reserve and Improves Sedation Safety Compared to Propofol in Endoscopic Retrograde Cholangiopancreatography. United European Gastroenterol J. 2025 Nov;13(9):1730-1739. doi: 10.1002/ueg2.70105. Epub 2025 Sep 5.
PubMed 40911638
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT06359834
- Acronym / sponsor ID
- 4-2023-1693
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- 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 one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam besylatePatient group who receives remimazolam for sedation during endoscopy |
| Propofol | Active comparator | Drug: PropofolPatient group who receives propofol for sedation during endoscopy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (age 19~80 yrs, ASA Class I~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph
Key exclusion criteria (1 listed)
- Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr >2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP <90mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure
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 |
|---|---|---|
| Remimazolam besylatePatients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. Remimazolam 2mg is added in case of inadequate sedation. | Drug | Remimazolam |
| PropofolPatients in this group receives 1mg/kg of propofol to induce sedation prior to endoscope insertion. Propofol 20mg is added in case of inadequate sedation. | Drug | Propofol |
Primary outcome
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
Time frame: Evaluation begins after sedative administration until the end of endoscopic procedure.
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.
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 24 Sep 2024.
- Derived from this study: PubMed 40911638Kim JH, Lee K, Lee SJ, Leem G, Lee HS, Park JY, Bang S, Park SW, Kim N, Chung MJ. Remimazolam Preserves Oxygen Reserve and Improves Sedation Safety Compared to Propofol in Endoscopic Retrograde Cholangiopancreatography. United European Gastroenterol J. 2025 Nov;13(9):1730-1739. doi: 10.1002/ueg2.70105. Epub 2025 Sep 5.
- Individual participant dataSharing planned: No
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 Remimazolam besylate and Propofol in people with Hepatobiiliary Diseases Requiring 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 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 24 Sep 2024. 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?
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation (time frame: Evaluation begins after sedative administration until the end of endoscopic procedure.). 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 NCT06359834, 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 24 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.