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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | Patient group who receives remimazolam for sedation during endoscopy |
|
| Propofol | Active Comparator | Patient group who receives propofol for sedation during endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluation begins after sedative administration until the end of endoscopic procedure. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sung Kwan Shin | Department of Internal Medicine, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Patients in this group receives 0.5mg/kg of propofol to induce sedation prior to endoscope insertion. |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |