Postoperative Sore ThroatNCT07895069
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
A study testing Polycamomile Lidocaine Gel and Lidocaine Glue in people with Postoperative Sore Throat, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Total anesthesia is the most commonly used anesthesia method in clinical surgery, which can reduce hospital stay and improve patient comfort on the basis of ensuring patient surgery safety. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Polycamomile Lidocaine Gel and Lidocaine Glue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years, ASA physical status III, BMI 18 to 30 kg/m²
- Inpatient scheduled for thoracic resection of lung lesion
- Mallampati airway classification I or II
- Voluntary participant providing written informed consent
Who cannot join
- Pregnant or lactating individuals
- Known allergy or intolerance to the study local anesthetics
- Severe cardiovascular, hepatic, or renal disease
- Symptoms of upper respiratory tract infection within the prior 7 days
- History of difficult intubation
- Active smoking or history of chronic pharyngitis
Show all 9Show fewer
- Prior oropharyngeal surgery
- Investigator-assessed unsuitability for study participation for any other reason
- Refusal to participate in the study
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
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400000
Jie Chen, +86 13527517763, 305045@hospital.cqmu.edu
About this study
Total anesthesia is the most commonly used anesthesia method in clinical surgery, which can reduce hospital stay and improve patient comfort on the basis of ensuring patient surgery safety. However, for patients with total anaesthetic tracheotomy, the incidence of throat complications such as throat pain, wheezing, and coughing after tracheotomy removal remains high. According to literature reports, the incidence of throat pain can reach 40% after total anaesthetic tracheotomy removal, the incidence of wheezing is 24%, and the related throat symptoms can persist until 24 hours or even longer after surgery. This phenomenon is particularly notable in patients with thoracic surgery.The high incidence of laryngeal pain after thoracic surgery is the result of the combination of mechanical stimulation of the bronchial / bilateral bronchial catheter, air sac pressure, surgery time and position, individual susceptibility factors of the patient, and technical details of intubation/entubation. Although such laryngeal complications are milder compared to other anesthetic complications, they can reduce the patient's post-operative hospitalization comfort and satisfaction, and even prolong the hospitalization time, affecting clinical treatment effectiveness and patient admission experience.This study aims to explore the effect of polycamomile lidocaine gel as a bronchial catheter lubricant on postoperative laryngeal complications in patients undergoing thoracic surgery. It aims to provide new ideas and clinical basis for optimizing clinical drug administration protocols and reducing the incidence of postoperative laryngeal complications for patients undergoing thoracic surgery with total anaesthetic bronchial intubation.
- Conditions
- Postoperative Sore Throat
- Being tested
- Polycamomile Lidocaine Gel, Lidocaine Glue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycamomile Lidocaine GelDrug
2 g of polycamomile lidocaine gel was uniformly applied from the tip of the tracheal tube to 1/3 of the front
Lidocaine GlueDrug
Uniformly apply 2g lidocaine glue from tip to front 1/3 of the end of the tracheal tube
| Study group | Role | What they receive |
|---|---|---|
| Complex Camomile Lidocaine group | Experimental | Not described Receives: Drug: Polycamomile Lidocaine Gel |
| Lidocaine Glue group | Placebo comparator | Not described Receives: Drug: Lidocaine Glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-corrected delta in CPPS (dB) for the sustained vowel /ɑ/ stable segment at 6 hours post-extubation (ΔCPPS₆ₕ = CPPS₆ₕ - CPPSₚᵣₑ)
Measured: Six hours after extubation
Secondary outcomes (2)
The ΔCPPS values at 1, 24, and 48 hours after extubation
Measured: 1 hour, 24 hours and 48 hours after the removal of the tracheal tube
After extubation, the laryngoscope was used to grade the throat condition; the incidence of throat pain and cough was related to the grade.
Measured: 1 hour, 24 hours, and 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore ThroatStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Chen, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895069
- Sponsor's protocol ID
- 2026-IIT-SL-159
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
郎宇，王天龙，张雁华，张敏，利多卡因凝胶作为喉罩润滑剂的临床观察•临床麻醉学杂志，2010，26（9）：817-818.
Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
PubMed 26171894Wang S, Wang H, Lei B, Xu L, Wang L, Wang G; Collaborators. Impact of Compound Chamomile and Lidocaine Hydrochloride Gel on Airway Complications Associated With Laryngeal Mask Airway: A Prospective, Multicenter, Randomized Controlled Trial. Anesth Analg. 2025 Oct 1;141(4):918-920. doi: 10.1213/ANE.0000000000007519. Epub 2025 Apr 4. No abstract available.
PubMed 40184312
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
- ClinicalTrials.gov ID
- NCT07895069
- Acronym / sponsor ID
- 2026-IIT-SL-159
- Conditions
- Postoperative Sore Throat
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 26 Oct 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.
Total anesthesia is the most commonly used anesthesia method in clinical surgery, which can reduce hospital stay and improve patient comfort on the basis of ensuring patient surgery safety. However, for patients with total anaesthetic tracheotomy, the incidence of throat complications such as throat pain, wheezing, and coughing after tracheotomy removal remains high. According to literature reports, the incidence of throat pain can reach 40% after total anaesthetic tracheotomy removal, the incidence of wheezing is 24%, and the related throat symptoms can persist until 24 hours or even longer after surgery. This phenomenon is particularly notable in patients with thoracic surgery.The high incidence of laryngeal pain after thoracic surgery is the result of the combination of mechanical stimulation of the bronchial / bilateral bronchial catheter, air sac pressure, surgery time and position, individual susceptibility factors of the patient, and technical details of intubation/entubation. Although such laryngeal complications are milder compared to other anesthetic complications, they can reduce the patient's post-operative hospitalization comfort and satisfaction, and even prolong the hospitalization time, affecting clinical treatment effectiveness and patient admission experience.This study aims to explore the effect of polycamomile lidocaine gel as a bronchial catheter lubricant on postoperative laryngeal complications in patients undergoing thoracic surgery. It aims to provide new ideas and clinical basis for optimizing clinical drug administration protocols and reducing the incidence of postoperative laryngeal complications for patients undergoing thoracic surgery with total anaesthetic bronchial intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Camomile Lidocaine group | Experimental | Drug: Polycamomile Lidocaine Gel |
| Lidocaine Glue group | Placebo comparator | Drug: Lidocaine Glue |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years, ASA physical status III, BMI 18 to 30 kg/m²
- Inpatient scheduled for thoracic resection of lung lesion
- Mallampati airway classification I or II
- Voluntary participant providing written informed consent
Key exclusion criteria (9 listed)
- Pregnant or lactating individuals
- Known allergy or intolerance to the study local anesthetics
- Severe cardiovascular, hepatic, or renal disease
- Symptoms of upper respiratory tract infection within the prior 7 days
- History of difficult intubation
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 |
|---|---|---|
| Polycamomile Lidocaine Gel2 g of polycamomile lidocaine gel was uniformly applied from the tip of the tracheal tube to 1/3 of the front | Drug | Complex Camomile Lidocaine group |
| Lidocaine GlueUniformly apply 2g lidocaine glue from tip to front 1/3 of the end of the tracheal tube | Drug | Lidocaine Glue group |
Primary outcome
Baseline-corrected delta in CPPS (dB) for the sustained vowel /ɑ/ stable segment at 6 hours post-extubation (ΔCPPS₆ₕ = CPPS₆ₕ - CPPSₚᵣₑ)
Time frame: Six hours after extubation
2 secondary outcomes
The ΔCPPS values at 1, 24, and 48 hours after extubation
Time frame: 1 hour, 24 hours and 48 hours after the removal of the tracheal tube
After extubation, the laryngoscope was used to grade the throat condition; the incidence of throat pain and cough was related to the grade.
Time frame: 1 hour, 24 hours, and 48 hours after extubation
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 26 Oct 2026.
- Background郎宇，王天龙，张雁华，张敏，利多卡因凝胶作为喉罩润滑剂的临床观察•临床麻醉学杂志，2010，26（9）：817-818.
- Background: PubMed 26171894Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.
- Background: PubMed 40184312Wang S, Wang H, Lei B, Xu L, Wang L, Wang G; Collaborators. Impact of Compound Chamomile and Lidocaine Hydrochloride Gel on Airway Complications Associated With Laryngeal Mask Airway: A Prospective, Multicenter, Randomized Controlled Trial. Anesth Analg. 2025 Oct 1;141(4):918-920. doi: 10.1213/ANE.0000000000007519. Epub 2025 Apr 4. No abstract available.
- 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 Polycamomile Lidocaine Gel and Lidocaine Glue in people with Postoperative Sore Throat, run by The Second Affiliated Hospital of Chongqing Medical University 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 4 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 26 Oct 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. Some participants in this study may receive a placebo. 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 Yuhan Wang Yuhan Wang (+86 18872341852, Wyh470810@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-corrected delta in CPPS (dB) for the sustained vowel /ɑ/ stable segment at 6 hours post-extubation (ΔCPPS₆ₕ = CPPS₆ₕ - CPPSₚᵣₑ) (time frame: Six hours after extubation). 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 NCT07895069, which also lists 3 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 26 Oct 2026.