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During endoscopy, the patient is sedated to relieve pain and improve the ease of the procedure. Sedation endoscopy using propofol is effective, but has the disadvantage that cardiopulmonary side effects are frequently observed. However, etomidate is known to have hemodynamic and respiratory stability.The purpose of this study was to compare the efficacy and safety of etomidate and propofol in sedated gastric endoscopic submucosal dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator | induction - 0.5mg/kg Propofol maintenance - 0.25mg/kg Propofol |
|
| Etomidate | Experimental | induction - 0.25mg/kg Propofol + 0.05mg/kg Etomidate maintenance - 0.05mg/kg Etomidate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etomidate Injection | Drug | Proofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory adverse event | the number and proportion of cases of respiratory depression | during gastric endoscopic submucosal dissection |
| Measure | Description | Time Frame |
|---|---|---|
| ESD clinical outcomes | tumor location, tumor pathology, ESD specimen size, En-bloc resection, submucosal invasion, margin positive | From enrollment to the first clinic visit (within 60 days) |
| Adverse events and procedure interruptions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | Seoung-buk Gu | 02841 | South Korea |
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| ID | Term |
|---|---|
| D005045 | Etomidate |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Propofol Injection | Drug | Proofol and etomidate are drugs used for sedation and have the same white color. Gastric endoscopic submucosal dissection is performed using propofol in the control group and etomidate in the experimental group. Efficacy and safety of sedatives were confirmed using propofol and etomidate. |
|
Overall adverse events Cardiopulmonary adverse events Procedure-related adverse events
Overall procedure interruption procedure interruption due to cardiopulmonary adverse events procedure interruption due to procedure-related adverse events
| during gastric endoscopic submucosal dissection |
| Sedation-related profile | administered dose of sedatives (induction dose, maintenance dose, total dose), induction time, awake time, sedation time | From initial administering the sedative drug to endoscopy room discharge (up to 2 hours); dose (ml) |
| Satisfaction assessment | patient satisfaction regarding sedation, doctor and nurse satisfaction regarding sedation during ESD | From initial administering the sedative drug to endoscopy room discharge; satisfaction score (0-10, 10 is the highest score) |
| Hemodynamic changes | systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, heart rate, oxygen saturation | From date of randomization until the date of first documented progression (up to 2 hours) |
| Factors associated with adverse events | factor analysis regarding overall adverse events factor analysis regarding overall cardiopulmonary adverse events factor analysis regarding overall procedure adverse events | From date of randomization until the date of first documented progression (up to three days) |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |