Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

Kim, Young Sung

Status and phase: Not yet enrolling; Phase 4

Conditions: Ordinary Disorder Needed Planned Surgery and General Anesthesia

Treatments: Drug: Placebo; Drug: Tegoprazan; Drug: Famotidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06743243

KCAB_032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

174 participants in 3 patient groups, including a placebo group

Group T

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan

Group F

Active Comparator group

Description:

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

Treatment:

Drug: Famotidine

Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo