Clinical trial NCT06729307: Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
Official title: Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Esophagogastroduodensocopy (EGD) Procedure
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall discomfort of patients
timeFrame: from the start of the endoscopic process to the end of the endoscopic process
Secondary outcomes:
measure: Intensity of gagging evaluated by patients
timeFrame: from the start of the endoscopic process to the end of the endoscopic process
measure: Intensity of patient gagging evaluated by endoscopist
timeFrame: from the start of the endoscopic process to the end of the endoscopic process
measure: Patient willingness to undergo unsedated EGD again
timeFrame: at the end of the endoscopic process
measure: Endoscopist satisfaction
timeFrame: from the start to the end of the endoscopic process
Other outcomes:
Locations:
Study officials:
References: