General Anesthesia
Conditions
Keywords
K-CAB, K-CAB OD tab., P-CAB, Famotidine, Tegoprazan, general anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGTegoprazan
Tegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia.
DRUGFamotidine
Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia.
DRUGPlacebo
Tegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia.
Sponsors
Korea University Guro Hospital
HK inno.N Corporation
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Asan Medical Center
Seok Kyeong Oh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Has a plan to undergo surgery with general anesthesia with inhalation or total Intravenous 2. Subjects aged between 20 and 69 years 3. ASA classification I - III
Exclusion criteria
1. Conduct Emergency surgery 2. BMI(Body Mass Index) ≥ 35 3. Has a history of drug abuse or depandency. 4. Has a history of Anesthetic allergy 5. Has a plan to undergo resection(gastric cancer, esophageal cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric pH right after endotracheal intubation | right after endotracheal intubation |
Secondary
| Measure | 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 | 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 |
Countries
South Korea
Outcome results
None listed