Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dyclonine hydrochloride mucilage, Tetracaine Hydrochloride Jelly.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Symptoms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dyclonine Hydrochloride Mucilage Versus Tetracaine Hydrochloride Jelly for Local Anesthesia in Unsedated Gastroscopy: A Non-inferiority Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug Dyclonine hydrochloride mucilage
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. - Drug Tetracaine Hydrochloride Jelly
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 outcome measures
- Visual Analogue Scale(VAS) Score [Time frame: Within 5 minutes after completion of gastroscopy]
Secondary outcome measures (11)
- Patient-reported palatability acceptability [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 [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 [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) [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 [Time frame: Within 5 minutes after completion of gastroscopy]
- Incidence of adverse events [Time frame: Throughout the procedure and within 30 minutes after completion of gastroscopy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Gastroenterology,General Hospital of Northern Theater Command — Shenyang
Publications
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07691346 · XHNKKY-DTRCT