Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

2. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

208

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Liaoning
      • Shenyang, Liaoning, Kina
        • Department of Gastroenterology,General Hospital of Northern Theater Command
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dyclonine Group
Medicin: 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.
Aktiv komparator: Tetracaine Group
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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).
Within 1-2 minutes of buccal or spray administration
Incidence of nausea and vomiting
Tidsramme: Throughout the procedure and within 30 minutes after completion of gastroscopy
Throughout the procedure and within 30 minutes after completion of gastroscopy
First-pass success rate
Tidsramme: Throughout the intubation process
Throughout the intubation process
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
Procedure time from endoscope insertion to withdrawal
Satisfaction of participant and endoscopist
Tidsramme: Within 5 minutes after completion of gastroscopy
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)
Tidsramme: Within 5 minutes after completion of gastroscopy
Within 5 minutes after completion of gastroscopy
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.
Throughout the entire gastroscopy procedure
Pharyngeal numbness after gastroscopy
Tidsramme: Within 5 minutes after completion of gastroscopy
Within 5 minutes after completion of gastroscopy
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
Incidence of adverse events
Tidsramme: Throughout the procedure and within 30 minutes after completion of gastroscopy
Incidence of dizziness, headache, choking/coughing.
Throughout the procedure and within 30 minutes after completion of gastroscopy

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
30 minutes prior to gastroscopy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

General Hospital of Shenyang Military Region

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • XHNKKY-DTRCT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gastrointestinale symptomer

Kliniske forsøg med Dyclonine hydrochloride mucilage

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Qatar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner