Esophagogastroduodensocopy (EGD) ProcedurePhase 4NCT06729307
Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
A Phase 4 study testing Oral ondansetron and dyclonine hydrochloride mucilage and Dyclonine hydrochloride mucilage in people with Esophagogastroduodensocopy (EGD) Procedure, run by Peking Union Medical College Hospital.
Trial summary
The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Esophagogastroduodensocopy (EGD) Procedure
- What is being tested?
- Oral ondansetron and dyclonine hydrochloride mucilage and Dyclonine hydrochloride mucilage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for diagnostic EGD: patients with symptoms in which EGD may influence di-agnosis and/or disease management, including dysphagia, odynophagia, esophageal refluc symptoms, persistent vomiting, gastrointestinal bleeding, and other upper gastrointestinal symptoms.
- Signing a written informed consent.
Who cannot join
- Contraindications for esophagogastroduodenoscopy.
- History of upper gastrointestinal tract surgery.
- Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
- Pregnancy.
- Neuropsychiatric disorders, severe depression and severe anxiety.
- Allergy to ondansetron or dyclonine hydrochloride.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects.
Read more
Participants will be treated with one of the following regimens according to the randomization result:
- Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
- dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.
After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:
- Overall discomfort;
- Intensity of gagging;
- Willingness to undergo unsedated EGD again if indicated.
- Being tested
- Oral ondansetron and dyclonine hydrochloride mucilage, Dyclonine hydrochloride mucilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ondansetron and dyclonine hydrochloride mucilageDrug
Patients will take 8 mg oral ondansetron 2 hours prior to EGD process in addition to dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to EGD process.
Dyclonine hydrochloride mucilageDrug
Patients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g/mL) and gurgle for 1 minute 15 minutes prior to endoscopic process.
| Study group | Role | What they receive |
|---|---|---|
| oral ondansetron and dyclonine hydrochloride mucilage | Experimental | Not described Receives: Drug: Oral ondansetron and dyclonine hydrochloride mucilage |
| dyclonine hydrochloride mucilage only | Other | Patients are treated with only topical pharyngeal anesthesia (dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process), with no antiemetic drug or placebo. Receives: Drug: Dyclonine hydrochloride mucilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall discomfort of patients
measured by NRS 0-10 (0 no discomfort, 10 as uncomfortable as can be), in a questionnaire given to patients after the endoscopic process is finished
Measured: from the start of the endoscopic process to the end of the endoscopic process
Secondary outcomes (4)
Intensity of gagging evaluated by patients
measured by NRS 0-10 (0 none, 10 extremely strong), in a questionnaire given to patients after the endoscopic process is finished
Measured: from the start of the endoscopic process to the end of the endoscopic process
Intensity of patient gagging evaluated by endoscopist
measured by NRS 0-10, (0 none, 10 extremely strong) in a questionnaire given to endoscopists after the endoscopic process is finished
Measured: from the start of the endoscopic process to the end of the endoscopic process
Patient willingness to undergo unsedated EGD again
the willingness of patients to undergo unsedated EGD in the same method again, assessed by NRS 0-10 (0, not willing at all; 10 completely willing).
Measured: at the end of the endoscopic process
Endoscopist satisfaction
satisfaction of endoscopist in this process, assessed by NRS 0-10 (0, not satisfied at all; 10 very satisfied).
Measured: from the start to the end of the endoscopic process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastroduodensocopy (EGD) ProcedureStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729307
- Sponsor's protocol ID
- 2024-OUEGD
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
- ClinicalTrials.gov ID
- NCT06729307
- Acronym / sponsor ID
- 2024-OUEGD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 11 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 goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:
Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects.
Participants will be treated with one of the following regimens according to the randomization result:
- Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
- dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.
After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:
- Overall discomfort;
- Intensity of gagging;
- Willingness to undergo unsedated EGD again if indicated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral ondansetron and dyclonine hydrochloride mucilage | Experimental | Drug: Oral ondansetron and dyclonine hydrochloride mucilage |
| dyclonine hydrochloride mucilage only | Other | Drug: Dyclonine hydrochloride mucilagePatients are treated with only topical pharyngeal anesthesia (dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process), with no antiemetic drug or placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients indicated for diagnostic EGD: patients with symptoms in which EGD may influence di-agnosis and/or disease management, including dysphagia, odynophagia, esophageal refluc symptoms, persistent vomiting, gastrointestinal bleeding, and other upper gastrointestinal symptoms.
- Signing a written informed consent.
Key exclusion criteria (6 listed)
- Contraindications for esophagogastroduodenoscopy.
- History of upper gastrointestinal tract surgery.
- Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
- Pregnancy.
- Neuropsychiatric disorders, severe depression and severe anxiety.
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 |
|---|---|---|
| Oral ondansetron and dyclonine hydrochloride mucilagePatients will take 8 mg oral ondansetron 2 hours prior to EGD process in addition to dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to EGD process. | Drug | oral ondansetron and dyclonine hydrochloride mucilage |
| Dyclonine hydrochloride mucilagePatients will be instructed to gurgle 10 mL of dyclonine chloride mucilage (0.01 g/mL) and gurgle for 1 minute 15 minutes prior to endoscopic process. | Drug | dyclonine hydrochloride mucilage only |
Primary outcome
Overall discomfort of patients
Time frame: from the start of the endoscopic process to the end of the endoscopic process
measured by NRS 0-10 (0 no discomfort, 10 as uncomfortable as can be), in a questionnaire given to patients after the endoscopic process is finished
4 secondary outcomes
Intensity of gagging evaluated by patients
Time frame: from the start of the endoscopic process to the end of the endoscopic process
Intensity of patient gagging evaluated by endoscopist
Time frame: from the start of the endoscopic process to the end of the endoscopic process
Patient willingness to undergo unsedated EGD again
Time frame: at the end of the endoscopic process
Endoscopist satisfaction
Time frame: from the start to the end of the endoscopic process
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral ondansetron and dyclonine hydrochloride mucilage and Dyclonine hydrochloride mucilage in people with Esophagogastroduodensocopy (EGD) Procedure, run by Peking Union Medical College Hospital.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Min (+86 15313350760, minyy19@student.pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall discomfort of patients (time frame: from the start of the endoscopic process to the end of the endoscopic process). 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 11 Dec 2024.