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Enrolling by Invitation

NCT Number: NCT06743243

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.

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Key information

Conditions

General Anesthesia

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Medical Center, Guro Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tegoprazan

Drug

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

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.

Primary outcomes

  1. Gastric pH right after endotracheal intubation

    Time frame: right after endotracheal intubation

Secondary outcomes

  1. 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)

  2. Gastric volume evaluated by Ultrasound

    Time frame: before anesthesia, right after end of surgery, 30 minutes after enter the postanesthesia care unit

  3. 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

Sponsors and collaborators

Lead sponsor

Seok Kyeong Oh

Other

Collaborators

  • Asan Medical Center
  • Eunpyeong St. Mary's Hospital, The Catholic University of Korea
  • HK inno.N Corporation
  • Korea University Guro Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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