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NCT Number: NCT07691346

Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

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.

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Key information

Conditions

Gastrointestinal Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology,General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location contact

Xingshun Qi

CONTACT

[email protected]

18909881019

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Willing to provide written informed consent voluntarily.

Exclusion criteria

  • 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;
  • Dysphagia or trismus (limited mouth opening);
  • Contraindications to upper gastrointestinal endoscopy, including acute perforation and active massive bleeding;
  • Mental or cognitive disorders that may preclude cooperation with the procedure;
  • Scheduled for therapeutic endoscopic procedures with an anticipated procedure time exceeding 15 minutes;
  • Altered upper gastrointestinal anatomy due to prior total gastrectomy, esophagectomy, or subtotal gastrectomy.

Treatment and study plan

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.

Primary outcomes

  1. Visual Analogue Scale(VAS) Score

    Time frame: Within 5 minutes after completion of gastroscopy

    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

  1. Patient-reported palatability acceptability

    Time frame: Within 1-2 minutes of buccal or spray administration

    Palatability acceptability was rated on a 3-level scale ( good, moderate, poor).

  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

    Time frame: Time of gastroscopy insertion into the gastric body

    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.

  5. Duration of gastroscopy

    Time frame: Procedure time from endoscope insertion to withdrawal

  6. Satisfaction of participant and endoscopist

    Time frame: Within 5 minutes after completion of gastroscopy

    Satisfaction is assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied.

  7. Willingness to repeat gastroscopy (yes/no)

    Time frame: Within 5 minutes after completion of gastroscopy

  8. Procedure-related pain score (VAS, 0-10)

    Time frame: Throughout the entire gastroscopy procedure

    Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), higher scores indicate more severe pain.

  9. Pharyngeal numbness after gastroscopy

    Time frame: Within 5 minutes after completion of gastroscopy

  10. Swallowing function (assessed by salivary swallowing difficulty) after gastroscopy

    Time frame: Within 5 minutes after completion of 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.

  11. Incidence of adverse events

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

    Incidence of dizziness, headache, choking/coughing.

Other outcomes

  1. Pre-procedural anxiety assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS).

    Time frame: 30 minutes prior to gastroscopy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haoran Jia

CONTACT

[email protected]

13730977073

Xingshun Qi

CONTACT

[email protected]

18909881019

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Dyclonine Hydrochloride Mucilage Versus Tetracaine Hydrochloride Jelly for Local Anesthesia in Unsedated Gastroscopy: A Non-inferiority Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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