Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

NCT06743243 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: KCAB_032
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

K-CAB; K-CAB OD tab.; P-CAB; Famotidine; Tegoprazan; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Gastric pH right after endotracheal intubation

  right after endotracheal intubation

Secondary Outcomes (3)

• 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

Study Arms (3)

Group T

EXPERIMENTAL

Tegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia.

Drug: Tegoprazan

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.

Drug: Famotidine

Group C

PLACEBO COMPARATOR

Tegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia.

Drug: Placebo

Interventions

Tegoprazan DRUG

Tegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia.

Group T

Famotidine DRUG

Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia.

Group F

Placebo DRUG

Tegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia.

Group C

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Korea University Medical Center, Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

tegoprazan; Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

KR (1)