Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Visual Analogue Scale(VAS) Score [Срок оценки: Within 5 minutes after completion of gastroscopy]

Вторичные конечные точки (11)

• Patient-reported palatability acceptability [Срок оценки: Within 1-2 minutes of buccal or spray administration]
• Incidence of nausea and vomiting [Срок оценки: Throughout the procedure and within 30 minutes after completion of gastroscopy]
• First-pass success rate [Срок оценки: Throughout the intubation process]
• Antifoaming efficacy [Срок оценки: Time of gastroscopy insertion into the gastric body]
• Duration of gastroscopy [Срок оценки: Procedure time from endoscope insertion to withdrawal]
• Satisfaction of participant and endoscopist [Срок оценки: Within 5 minutes after completion of gastroscopy]
• Willingness to repeat gastroscopy (yes/no) [Срок оценки: Within 5 minutes after completion of gastroscopy]
• Procedure-related pain score (VAS, 0-10) [Срок оценки: Throughout the entire gastroscopy procedure]
• Pharyngeal numbness after gastroscopy [Срок оценки: Within 5 minutes after completion of gastroscopy]
• Swallowing function (assessed by salivary swallowing difficulty) after gastroscopy [Срок оценки: Within 5 minutes after completion of gastroscopy]
• Incidence of adverse events [Срок оценки: Throughout the procedure and within 30 minutes after completion of gastroscopy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Gastroenterology,General Hospital of Northern Theater Command — Шэньян

Публикации

• 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

Идентификаторы

NCT: NCT07691346 · XHNKKY-DTRCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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