Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tegoprazan, Famotidine, Placebo.
- Who it may be relevant to
- Registry conditions: General Anesthesia. Basic parameters: 20 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Tegoprazan
Tegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia. - Drug Famotidine
Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia. - Drug Placebo
Tegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia.
Primary outcome measures
- Gastric pH right after endotracheal intubation [Time frame: right after endotracheal intubation]
Secondary outcome measures (3)
- Change of oral, esophageal and gastric pH [Time frame: 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 [Time frame: 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.) [Time frame: before anesthesia, right after intubation, 30 minutes after surgery started, right after surgery end, extubation, 30 minutes after enter the postanesthesia care unit]
Eligibility criteria
Inclusion criteria
- Has a plan to undergo surgery with general anesthesia with inhalation or total Intravenous
- Subjects aged between 20 and 69 years
- ASA classification I - III
Exclusion criteria
- Conduct Emergency surgery
- BMI(Body Mass Index) ≥ 35
- Has a history of drug abuse or depandency.
- Has a history of Anesthetic allergy
- Has a plan to undergo resection(gastric cancer, esophageal cancer)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Korea University Medical Center, Guro Hospital — Seoul
Identifiers
NCT: NCT06743243 · KCAB_032