Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy
10. september 2026 oppdatert av: Xingshun Qi, General Hospital of Shenyang Military Region
Dyclonine Hydrochloride Mucilage Versus Tetracaine Hydrochloride Jelly for Local Anesthesia in Unsedated Gastroscopy: A Non-inferiority Randomized Controlled Trial
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
208
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xingshun Qi
- Telefonnummer: 18909881019
- E-post: xingshunqi@126.com
Studer Kontakt Backup
- Navn: Haoran Jia
- Telefonnummer: 13730977073
- E-post: 2976851089@qq.com
Studiesteder
-
-
Liaoning
-
Shenyang, Liaoning, Kina
- Department of Gastroenterology,General Hospital of Northern Theater Command
-
Ta kontakt med:
- Xingshun Qi
- Telefonnummer: 18909881019
- E-post: xingshunqi@126.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dyclonine Group
|
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.
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Aktiv komparator: Tetracaine Group
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale(VAS) Score
Tidsramme: 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.
|
Within 5 minutes after completion of gastroscopy
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-reported palatability acceptability
Tidsramme: Within 1-2 minutes of buccal or spray administration
|
Palatability acceptability was rated on a 3-level scale ( good, moderate, poor).
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Within 1-2 minutes of buccal or spray administration
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Incidence of nausea and vomiting
Tidsramme: Throughout the procedure and within 30 minutes after completion of gastroscopy
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Throughout the procedure and within 30 minutes after completion of gastroscopy
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First-pass success rate
Tidsramme: Throughout the intubation process
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Throughout the intubation process
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Antifoaming efficacy
Tidsramme: 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. |
Time of gastroscopy insertion into the gastric body
|
|
Duration of gastroscopy
Tidsramme: Procedure time from endoscope insertion to withdrawal
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Procedure time from endoscope insertion to withdrawal
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|
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Satisfaction of participant and endoscopist
Tidsramme: Within 5 minutes after completion of gastroscopy
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Satisfaction is assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied.
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Within 5 minutes after completion of gastroscopy
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Willingness to repeat gastroscopy (yes/no)
Tidsramme: Within 5 minutes after completion of gastroscopy
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Within 5 minutes after completion of gastroscopy
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Procedure-related pain score (VAS, 0-10)
Tidsramme: 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.
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Throughout the entire gastroscopy procedure
|
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Pharyngeal numbness after gastroscopy
Tidsramme: Within 5 minutes after completion of gastroscopy
|
Within 5 minutes after completion of gastroscopy
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Swallowing function (assessed by salivary swallowing difficulty) after gastroscopy
Tidsramme: 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. |
Within 5 minutes after completion of gastroscopy
|
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Incidence of adverse events
Tidsramme: Throughout the procedure and within 30 minutes after completion of gastroscopy
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Incidence of dizziness, headache, choking/coughing.
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Throughout the procedure and within 30 minutes after completion of gastroscopy
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pre-procedural anxiety assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Tidsramme: 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.
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30 minutes prior to gastroscopy
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
1. juli 2028
Studiet fullført (Antatt)
1. juli 2028
Datoer for studieregistrering
Først innsendt
26. juni 2026
Først innsendt som oppfylte QC-kriteriene
2. juli 2026
Først lagt ut (Faktiske)
8. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- XHNKKY-DTRCT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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