Gastrointestinal SymptomsNCT07691346
Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy
A study testing Dyclonine hydrochloride mucilage and Tetracaine Hydrochloride Jelly in people with Gastrointestinal Symptoms, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Dyclonine hydrochloride mucilage and Tetracaine Hydrochloride Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology,General Hospital of Northern Theater Command
Shenyang, Liaoning
Xingshun Qi, 18909881019, xingshunqi@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Dyclonine hydrochloride mucilage, Tetracaine Hydrochloride Jelly
- Keywords
- Non-inferiority Trial, Dyclonine Hydrochloride, Tetracaine Hydrochloride, Visual Analogue Scale, Topical Anesthesia, Gastroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyclonine hydrochloride mucilageDrug
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.
Tetracaine Hydrochloride JellyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyclonine Group | Experimental | Not described Receives: Drug: Dyclonine hydrochloride mucilage |
| Tetracaine Group | Active comparator | Not described Receives: Drug: Tetracaine Hydrochloride Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 minutes after completion of gastroscopy
Secondary outcomes (11)
Patient-reported palatability acceptability
Palatability acceptability was rated on a 3-level scale ( good, moderate, poor).
Measured: Within 1-2 minutes of buccal or spray administration
Incidence of nausea and vomiting
Measured: Throughout the procedure and within 30 minutes after completion of gastroscopy
First-pass success rate
Measured: 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.
Measured: Time of gastroscopy insertion into the gastric body
Duration of gastroscopy
Measured: 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.
Measured: Within 5 minutes after completion of gastroscopy
Willingness to repeat gastroscopy (yes/no)
Measured: 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.
Measured: Throughout the entire gastroscopy procedure
Pharyngeal numbness after gastroscopy
Measured: 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.
Measured: Within 5 minutes after completion of gastroscopy
Incidence of adverse events
Incidence of dizziness, headache, choking/coughing.
Measured: Throughout the procedure and within 30 minutes after completion of gastroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691346
- Sponsor's protocol ID
- XHNKKY-DTRCT
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38254013Han 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.
PubMed 33317460Abraham 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.
PubMed 15330904Jichao 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.
PubMed 26954876
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyclonine Hydrochloride Mucilage Versus Tetracaine Hydrochloride Jelly for Local Anesthesia in Unsedated Gastroscopy: A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691346
- Acronym / sponsor ID
- XHNKKY-DTRCT
- Conditions
- Gastrointestinal Symptoms
- Keywords
- Non-inferiority Trial, Dyclonine Hydrochloride, Tetracaine Hydrochloride, Visual Analogue Scale, Topical Anesthesia, Gastroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyclonine Group | Experimental | Drug: Dyclonine hydrochloride mucilage |
| Tetracaine Group | Active comparator | Drug: Tetracaine Hydrochloride Jelly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyclonine hydrochloride mucilageDyclonine 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 | Dyclonine Group |
| Tetracaine Hydrochloride JellyTetracaine 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. | Drug | Tetracaine Group |
Primary outcome
Visual Analogue Scale(VAS) Score
Time frame: 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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 38254013Wang 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.
- Background: PubMed 33317460Han 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.
- Background: PubMed 15330904Abraham 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.
- Background: PubMed 26954876Jichao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyclonine hydrochloride mucilage and Tetracaine Hydrochloride Jelly in people with Gastrointestinal Symptoms, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale(VAS) Score (time frame: Within 5 minutes after completion of gastroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07691346, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.