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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
208
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.
Department of Gastroenterology,General Hospital of Northern Theater Command
Shenyang, Liaoning, China
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
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