Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Tegoprazan; Drug: Famotidine; Drug: 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.

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Korea University Medical Center, Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group T; Tegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia.	Drug: Tegoprazan; Tegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia.
Active Comparator: Group F; Famotidine 20 mg/10 ml + Saline 10 ml IV + Tegoprazan OD tab. 50 mg placebo PO, 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.
Placebo Comparator: Group C; Tegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia.	Drug: Placebo; Tegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric pH right after endotracheal intubation	right after endotracheal intubation

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Seok Kyeong Oh
• Collaborators: Asan Medical Center; Korea University Guro Hospital; HK inno.N Corporation; Eunpyeong St. Mary's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: general anesthesia; Famotidine; P-CAB; Tegoprazan; K-CAB; K-CAB OD tab.
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Substandard Drugs; Pharmaceutical Preparations; Thiazoles; Azoles; Famotidine; Counterfeit Drugs; tegoprazan
• Other Study ID Numbers: KCAB_032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No