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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyclonine Group | Experimental |
| |
| Tetracaine Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported palatability acceptability | Palatability acceptability was rated on a 3-level scale ( good, moderate, poor). | Within 1-2 minutes of buccal or spray administration |
| Incidence of nausea and vomiting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes prior to gastroscopy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi | Contact | 18909881019 | xingshunqi@126.com | |
| Haoran Jia | Contact | 13730977073 | 2976851089@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,General Hospital of Northern Theater Command | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38254013 | Background | 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. | |
| 33317460 | 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. |
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| 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. |
|
| Throughout the procedure and within 30 minutes after completion of gastroscopy |
| First-pass success rate | Throughout the intubation process |
| 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 of gastroscopy insertion into the gastric body |
| Duration of gastroscopy | Procedure time from endoscope insertion to withdrawal |
| Satisfaction of participant and endoscopist | Satisfaction is assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied. | Within 5 minutes after completion of gastroscopy |
| Willingness to repeat gastroscopy (yes/no) | Within 5 minutes after completion of gastroscopy |
| Procedure-related pain score (VAS, 0-10) | Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), higher scores indicate more severe pain. | Throughout the entire gastroscopy procedure |
| Pharyngeal numbness after gastroscopy | Within 5 minutes after completion of gastroscopy |
| Swallowing function (assessed by salivary swallowing difficulty) after 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. | Within 5 minutes after completion of gastroscopy |
| Incidence of adverse events | Incidence of dizziness, headache, choking/coughing. | Throughout the procedure and within 30 minutes after completion of gastroscopy |
| 15330904 | 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. |
| 26954876 | 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. |