- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723627
Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
December 7, 2023 updated by: Yonsei University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sung Kwan Shin
- Phone Number: 82-02-2228-1985
- Email: kaarma@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of
- Yonsei University Health system, Severance Hospital
-
Contact:
- Sung Kwan Shin
- Phone Number: 82-02-2228-1985
- Email: kaarma@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Patients (age 19~80 yrs, ASA Class I~III, ECOG 0~1) who are scheduled for elective diagnostic gastric endoscopy
Exclusion Criteria:
Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP <80mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remimazolam
Patient group who receives remimazolam for sedation during endoscopy
|
Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion.
|
Active Comparator: Propofol
Patient group who receives propofol for sedation during endoscopy
|
Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Evaluation begins after sedative administration until the end of endoscopic procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sung Kwan Shin, Department of Internal Medicine, Yonsei University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2023
Primary Completion (Actual)
September 21, 2023
Study Completion (Actual)
September 21, 2023
Study Registration Dates
First Submitted
February 1, 2023
First Submitted That Met QC Criteria
February 1, 2023
First Posted (Actual)
February 13, 2023
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2022-1369
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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