General AnesthesiaPhase 4NCT06743243
Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia
A Phase 4 study testing Tegoprazan and Famotidine in people with General Anesthesia, run by Seok Kyeong Oh at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Tegoprazan and Famotidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jul 2025to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- General Anesthesia
- Being tested
- Tegoprazan, Famotidine, Placebo
- Keywords
- K-CAB, K-CAB OD tab., P-CAB, Famotidine, Tegoprazan, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Tegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia. Receives: 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. Receives: Drug: Famotidine |
| Group C | Placebo comparator | Tegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric pH right after endotracheal intubation
Measured: right after endotracheal intubation
Secondary outcomes (3)
Change of oral, esophageal and gastric pH
Measured: 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
Measured: 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.)
Measured: before anesthesia, right after intubation, 30 minutes after surgery started, right after surgery end, extubation, 30 minutes after enter the postanesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start23 Jul 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seok Kyeong Oh
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, HK inno.N Corporation, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Asan Medical Center
- Responsible party
- Sponsor-investigator, Seok Kyeong Oh, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743243
- Sponsor's protocol ID
- KCAB_032
- Status last verified
- Aug 2025
- First submitted
- 16 Dec 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06743243
- Acronym / sponsor ID
- KCAB_032
- Conditions
- General Anesthesia
- Keywords
- K-CAB, K-CAB OD tab., P-CAB, Famotidine, Tegoprazan, general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Seok Kyeong OhUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital, HK inno.N Corporation, Eunpyeong St. Mary's Hospital, The Catholic University of Korea, Asan Medical Center
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Drug: TegoprazanTegoprazan OD tab. 50 mg PO + Saline 20 ml IV, one hour before general anesthesia. |
| Group F | Active comparator | Drug: FamotidineFamotidine 20 mg/10 ml + Saline 10 ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia. |
| Group C | Placebo comparator | Drug: PlaceboTegoprazan OD tab. 50 mg placebo PO + Saline 20 ml IV, one hour before general anesthesia. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegoprazanTegoprazan OD tab. 50 mg PO + Saline 20ml IV, one hour before general anesthesia. | Drug | Group T |
| FamotidineFamotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia. | Drug | Group F |
| PlaceboTegoprazan OD tab. 50 mg placebo PO + Saline 20ml IV, one hour before general anesthesia. | Drug | Group C |
Primary outcome
Gastric pH right after endotracheal intubation
Time frame: right after endotracheal intubation
3 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan and Famotidine in people with General Anesthesia, run by Seok Kyeong Oh at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric pH right after endotracheal intubation (time frame: right after endotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.