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Not yet recruitingNCT07895069Updated Oct 26, 2026

The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients

An interventional study of Polycamomile Lidocaine Gel and Lidocaine Glue in Postoperative Sore Throat, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Prevention

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Postoperative Sore Throat
03

In context

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 102 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 65 years, III, 18 to 30 kg/m²
  • Inpatient scheduled for thoracic resection of lung lesion
  • Mallampati airway classification I or II
  • Voluntary participant providing written

Exclusion criteria

Exclusion Criteria:

  • 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
  • Prior oropharyngeal surgery
  • Investigator-assessed unsuitability for study participation for any other reason
  • Refusal to participate in the study
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
330 participants (estimated)

Study arms

  • Experimental
    Complex Camomile Lidocaine group

    Drug: Polycamomile Lidocaine Gel

  • Placebo comparator
    Lidocaine Glue group

    Drug: Lidocaine Glue

Interventions

  • DrugPolycamomile Lidocaine Gel

    2 g of polycamomile lidocaine gel was uniformly applied from the tip of the tracheal tube to 1/3 of the front

  • DrugLidocaine Glue

    Uniformly apply 2g lidocaine glue from tip to front 1/3 of the end of the tracheal tube

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 site
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References and documents

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 26171894 ↗
  • Wang 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 26, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jan 31, 2028
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895069
Responsible party
Jie Chen (Attending Physician, The Second Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Yuhan Wang Yuhan Wang
Contact
Wyh470810@163.com
+86 18872341852

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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