Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

Phase 4

Not yet recruiting

• Conditions: Ordinary Disorder Needed Planned Surgery and General Anesthesia
• Interventions: Drug: Tegoprazan; Drug: Famotidine; Drug: Placebo

• Registration Number: NCT06743243
• Lead Sponsor: Kim, Young Sung

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-03
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Tegoprazan	Tegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia.
Group F	Famotidine	Famotidine 20 mg/10 ml + Saline 10 ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia.
Group C	Placebo	Tegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia.

Primary Outcome Measures

Name	Time	Method
Gastric pH right after endotracheal intubation	right after endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Medical Center, Guro Hospital; 🇰🇷 Seoul, Korea, Republic of