An interventional study of Dyclonine hydrochloride mucilage and Tetracaine Hydrochloride Jelly in Gastrointestinal Symptoms, sponsored by General Hospital of Shenyang Military Region. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by General Hospital of Shenyang Military Region · Not applicable, Interventional, and Treatment
Gastroscopy is a key diagnostic approach for upper gastrointestinal diseases, but pharyngeal passage of the gastroscopy often causes participants' discomfort. Topical pharyngeal anesthetics are routinely used to alleviate such discomfort. Dyclonine hydrochloride mucilage and tetracaine hydrochloride jelly are the two most commonly used topical pharyngeal anesthetics in clinical practice. Although both agents are widely used, their comparative efficacy in unsedated gastroscopy remains unclear, and high-quality evidence is scarce. This study aims to compare their anesthetic efficacy,participant comfort, and safety.
A total of 208 participants undergoing unsedated gastroscopy will be enrolled and randomly assigned in a 1:1 ratio to either the dyclonine group or the tetracaine group. Participants in the dyclonine group will receive dyclonine hydrochloride mucilage for pharyngeal topical anesthesia, whereas those in the tetracaine group will receive tetracaine hydrochloride jelly. The primary outcome is participant comfort assessed using the Visual Analogue Scale (VAS, range 0-10) during the gastroscopy. Secondary outcomes include antifoaming efficacy, the incidence of nausea and vomiting, the duration of gastroscopy, participant and endoscopist satisfaction, and the incidence of adverse events.
General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dyclonine hydrochloride mucilage
Drug: Tetracaine Hydrochloride Jelly
Dyclonine hydrochloride mucilage (10 ml: 0.1 g) will be used. Each participant will hold 10 ml of the solution in the throat for 2 minutes before swallowing, 10-15 minutes prior to gastroscopy.
Tetracaine hydrochloride jelly (specification: 10 g : 0.1 g) will be administered 10-15 minutes prior to gastroscopy. A nurse will spray the jelly onto the root of the participant's tongue and then instruct the participant to swallow it.
Visual Analogue Scale(VAS) Score
Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no discomfort) to 10 (worst possible discomfort), higher scores indicate worse outcome.
Time frame: Within 5 minutes after completion of gastroscopy
Patient-reported palatability acceptability
Palatability acceptability was rated on a 3-level scale ( good, moderate, poor).
Time frame: Within 1-2 minutes of buccal or spray administration
Incidence of nausea and vomiting
Time frame: Throughout the procedure and within 30 minutes after completion of gastroscopy
First-pass success rate
Time frame: Throughout the intubation process
Antifoaming efficacy
Assessed by the endoscopist using a 4-point grading scale: no bubbles or foam, view is clear; few bubbles present, but without interfering with mucosal evaluation; moderate amount of bubbles and foam, causing some difficulty in evaluation; abundant foam and bubbles, making mucosal evaluation hardly possible.
Time frame: Time of gastroscopy insertion into the gastric body
Duration of gastroscopy
Time frame: Procedure time from endoscope insertion to withdrawal
Satisfaction of participant and endoscopist
Satisfaction is assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied.
Time frame: Within 5 minutes after completion of gastroscopy
Willingness to repeat gastroscopy (yes/no)
Time frame: Within 5 minutes after completion of gastroscopy
Procedure-related pain score (VAS, 0-10)
Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), higher scores indicate more severe pain.
Time frame: Throughout the entire gastroscopy procedure
Pharyngeal numbness after gastroscopy
Time frame: Within 5 minutes after completion of gastroscopy
Swallowing function (assessed by salivary swallowing difficulty) after gastroscopy
Assessed by a 4-point grading scale: normal swallowing, no difficulty; mild difficulty, foreign body sensation but does not affect swallowing; moderate difficulty, obvious effort or mild choking; severe difficulty, unable to swallow saliva normally.
Time frame: Within 5 minutes after completion of gastroscopy
Incidence of adverse events
Incidence of dizziness, headache, choking/coughing.
Time frame: Throughout the procedure and within 30 minutes after completion of gastroscopy
Pre-procedural anxiety assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Items are scored on a 5-point Likert scale (1 = not at all to 5 = extremely). The anxiety subscale consists of four items related to worry about the anesthetic and the procedure, with total scores ranging from 4 to 20. Higher scores indicate higher anxiety levels.
Time frame: 30 minutes prior to gastroscopy
Plan to share: No
Start is estimated for Sep 2026; primary completion for Jul 2028, 21 months later.
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General Hospital of Shenyang Military Region