Diagnostic Gastric EndoscopyNCT05723627
Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
A study testing Remimazolam besylate and Propofol in people with Diagnostic Gastric Endoscopy, 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 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Gastric Endoscopy
- What is being tested?
- Remimazolam besylate and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2023to 21 Sep 2023
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (age 19~80 yrs, ASA Class I~III, ECOG 0~1) who are scheduled for elective diagnostic gastric endoscopy
Who cannot join
- Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP <80mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
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 diagnostic gastric endoscopy.
- Conditions
- Diagnostic Gastric Endoscopy
- 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.
PropofolDrug
Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.
| 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 posted13 Feb 2023
- Study start6 Apr 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Gastric EndoscopyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung Kwan Shin, Principal investigator, Department of Internal Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723627
- Sponsor's protocol ID
- 4-2022-1369
- Status last verified
- Dec 2023
- First submitted
- 1 Feb 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
- ClinicalTrials.gov ID
- NCT05723627
- Acronym / sponsor ID
- 4-2022-1369
- Conditions
- Diagnostic Gastric Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 13 Feb 2023 (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 diagnostic gastric endoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- 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
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (age 19~80 yrs, ASA Class I~III, ECOG 0~1) who are scheduled for elective diagnostic gastric endoscopy
Key exclusion criteria (1 listed)
- Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP <80mmHg) 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. | Drug | Remimazolam |
| PropofolPatients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion. | 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 8 Dec 2023.
Related trials for Diagnostic Gastric Endoscopy
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruiting
High-Flow Nasal Cannula Oxygenation During Sedated Gastrointestinal Endoscopy in Patients With Chronic Obstructive Pulmonary Disease
Hypoxemia, Gastric Cancer (Diagnosis)
Recruiting
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
Hypoxia, Esophageal Cancer
RecruitingObservational study
AI Model for Early Gastric Cancer Diagnosis Using Endoscopic Imaging
Early Gastric Cancer
Active, not recruitingObservational study
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease
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.
Sung Kwan Shin principal investigator
Department of Internal Medicine, Yonsei University College of Medicine
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 Diagnostic Gastric Endoscopy, 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 8 Dec 2023. 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?
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 8 Dec 2023.