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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| HK inno.N Corporation | INDUSTRY |
| Eunpyeong St. Mary's Hospital, The Catholic University of Korea | UNKNOWN |
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The aim of this study is to compare gastric pH right after endotracheal intubation for general anesthesia in patients pretreated with tegoprazan, famotidine, or placebo.
This clinical trial is a prospective, randomized, double-blind, multicenter, investigator-initiated trial that aims to demonstrate the preventive effect of tegoprazan on preoperative aspiration in patients scheduled to undergo surgery using general anesthesia.
Subjects who meet the inclusion/exclusion criteria will be randomly assigned to the tegoprazan administration group (Group T), famotidine administration group (Group F), or placebo administration group (Group C) in the same ratio of 1:1:1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Experimental | Tegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia. |
|
| Group F | Active Comparator | Famotidine 20 mg/10 ml + Saline 10 ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia. |
|
| Group C | Placebo Comparator | Tegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan | Drug | Tegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric pH right after endotracheal intubation | right after endotracheal intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Change of oral, esophageal and gastric pH | oral pH(before anesthesia, endotracheal intubation 30 minutes after surgery started, right after surgery end, extubation, 30minutes after enter the postanesthesia care unit), esophageal and gastric pH(right after intubation) | |
| Gastric volume evaluated by Ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Medical Center, Guro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Asan Medical Center |
| OTHER |
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| Famotidine | Drug | Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia. |
|
| Placebo | Drug | Tegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia. |
|
| before anesthesia, right after end of surgery, 30 minutes after enter the postanesthesia care unit |
| Risk of aspiration(pH < 2.5, Gastric volume > 0.4mL/kg) and frequency of complications(aspiration etc.) | before anesthesia, right after intubation, 30 minutes after surgery started, right after surgery end, extubation, 30 minutes after enter the postanesthesia care unit |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |