Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

NCT07691346 | Not Yet Recruiting

• 1 other identifier: XHNKKY-DTRCT
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Symptoms

Keywords

Non-inferiority Trial; Dyclonine Hydrochloride; Tetracaine Hydrochloride; Visual Analogue Scale; Topical Anesthesia; Gastroscopy

Outcome Measures

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.

  Within 5 minutes after completion of gastroscopy

Secondary Outcomes (11)

• Patient-reported palatability acceptability

  Within 1-2 minutes of buccal or spray administration

• Incidence of nausea and vomiting

  Throughout the procedure and within 30 minutes after completion of gastroscopy

• First-pass success rate

  Throughout the intubation process

• Antifoaming efficacy

  Time of gastroscopy insertion into the gastric body

• Duration of gastroscopy

  Procedure time from endoscope insertion to withdrawal

Other Outcomes (1)

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

  30 minutes prior to gastroscopy

Study Arms (2)

Dyclonine Group

EXPERIMENTAL

Drug: Dyclonine hydrochloride mucilage

Tetracaine Group

ACTIVE COMPARATOR

Drug: Tetracaine Hydrochloride Jelly

Interventions

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.

Dyclonine Group

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.

Tetracaine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology,General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Related Publications (4)

• Wang L, Wen QH, Wen LJ, Qin JM, Ren CM, Wen LM. Disturbance of consciousness caused by dyclonine hydrochloride mucilage: a case report. BMC Anesthesiol. 2024 Jan 22;24(1):34. doi: 10.1186/s12871-024-02407-x.

  PMID: 38254013 BACKGROUND

• Han C, Li P, Guo Z, Guo Y, Sun L, Chen G, Qiu X, Mi W, Zhang C, Berra L. Improving mucosal anesthesia for awake endotracheal intubation with a novel method: a prospective, assessor-blinded, randomized controlled trial. BMC Anesthesiol. 2020 Dec 14;20(1):301. doi: 10.1186/s12871-020-01210-8.

  PMID: 33317460 BACKGROUND

• Abraham NS, Fallone CA, Mayrand S, Huang J, Wieczorek P, Barkun AN. Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy: a Canadian randomized controlled cost-outcome study. Am J Gastroenterol. 2004 Sep;99(9):1692-9. doi: 10.1111/j.1572-0241.2004.40157.x.

  PMID: 15330904 BACKGROUND

• Jichao S, Cuida M, Mingxing C, Yunyun W, Dongdong Z. Oral dyclonine hydrochloride mucilage versus tetracaine spray in electronic flexible laryngoscopy: A prospective, randomized controlled trial. Am J Otolaryngol. 2016 Mar-Apr;37(2):169-71. doi: 10.1016/j.amjoto.2015.12.005. Epub 2015 Dec 9.

  PMID: 26954876 BACKGROUND

Central Study Contacts

Xingshun Qi

CONTACT

18909881019; xingshunqi@126.com

Haoran Jia

CONTACT

13730977073; 2976851089@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)