Oral Ondansetron to Improve Patient Experience of Unsedated Esophagogastroduodenoscopy Pilot Study

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Active, not recruiting

Phase 4

Conditions

Esophagogastroduodensocopy (EGD) Procedure

Treatments

Drug: ondansetron and dyclonine hydrochloride

Drug: dyclonine hydrochloride only

Study type

Interventional

Funder types

Other

Identifiers

NCT07264738

ON-COMFORT25

Details and patient eligibility

About

The goal of this interventional pilot study is to explore the feasibility of administering ondansetron prior to esophagogastroduodenoscopy (EGD), and preliminarily test if it can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:

Is adding oral ondansetron to pre-medication regimen of unsedated EGD safe, easy to conduct, and well-accepted by patients? May taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? May 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 answer the questions above.

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients scheduled for follow-up EGD at PUMCH
Signing a written informed consent.

Exclusion criteria

Contraindications for esophagogastroduodenoscopy.
History of upper gastrointestinal tract surgery.
With conditions indicated for emergency EGD, such as upper gastrointestinal bleeding
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.