About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, of either sex;
Scheduled for an unsedated gastroscopy;
American Society of Anesthesiologists (ASA) physical status class I or II;
Able to understand and cooperate with Visual Analogue Scale (VAS) comfort assessment;
Disqualifiers
Known allergy to the study agents;
Severe cardiopulmonary disease or hepatic/renal insufficiency;
Long-term use of sedatives or analgesics, or history of alcohol abuse;
Pregnancy or lactation;
Trial design
Parallel
Treatments tested in this trial
Dyclonine hydrochloride mucilage
DrugDyclonine 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
DrugTetracaine 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Patient-reported palatability acceptability
Palatability acceptability was rated on a 3-level scale ( good, moderate, poor).
Incidence of nausea and vomiting
First-pass success rate
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.
Other outcomes
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.
Sponsors and contacts
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