Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

Phase 4Enrolling By InvitationNCT06743243

Seok Kyeong Oh174 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

174

Conditions

General Anesthesia

Interventions

TegoprazanDRUG

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

FamotidineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

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)

Locations (1)

Korea University Medical Center, Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Gastric pH right after endotracheal intubation

Time frame: right after endotracheal intubation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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