Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral Hospital of Shenyang Military Region

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dyclonine hydrochloride mucilage

    Drug

    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

    Drug

    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.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Dyclonine GroupExperimental treatment 1 intervention
Group B: Tetracaine GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Incidence of nausea and vomiting

Time frame
Throughout the procedure and within 30 minutes after completion of gastroscopy
3

First-pass success rate

Time frame
Throughout the intubation process
4

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

Other outcomes

1

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

Sponsors and contacts

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