Postoperative Sore Throat, Cough, HoarsenessPhase 4STONESNCT07124650
Sore Throat After Open Neck Elective Surgery
A Phase 4 study testing Hydrocortisone Acetate 1% Ointment and Lidocaine hydrochloride 0,05% with chlorhexidine in people with Postoperative Sore Throat, Cough, Hoarseness and Thyroid and Parathyroid Surgery, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This randomized clinical trial aims to evaluate the effectiveness of two medications-hydrocortisone ointment and lidocaine solution-applied to the endotracheal tube in reducing postoperative throat pain, hoarseness, and cough following thyroid or parathyroid surgery with neuromonitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sore Throat, Cough, Hoarseness, Thyroid and Parathyroid Surgery
- What is being tested?
- Hydrocortisone Acetate 1% Ointment and Lidocaine hydrochloride 0,05% with chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2025to May 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective open surgery on the thyroid/parathyroid glands with intraoperative neuromonitoring.
- Age ≥18 years.
- Willing and able to provide voluntary informed consent for participation in the study.
Who cannot join
- Pregnancy (for women of childbearing potential).
- Known allergy to hydrocortisone or lidocaine.
- 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.
Russia1 site, 1 recruiting
- Recruiting
Saint Petersburg State University Hospital
Saint Petersburg
Sergey Efremov, 79137946090, efremovsergm@gmail.com
About this study
Official title: Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial
This randomized clinical trial aims to evaluate the effectiveness of two medications-hydrocortisone ointment and lidocaine solution-applied to the endotracheal tube in reducing postoperative throat pain, hoarseness, and cough following thyroid or parathyroid surgery with neuromonitoring.
A total of 764 adult patients undergoing elective neck surgery at Saint-Petersburg State University Hospital will be enrolled and randomly assigned to receive either a hydrocortisone-coated or lidocaine-coated endotracheal tube.
Read more
Outcomes will be assessed upon awakening from anesthesia, at 24 hours, and again at 3 days postoperatively.
The findings may contribute to improving postoperative comfort and recovery for patients undergoing similar surgical procedures.
- Being tested
- Hydrocortisone Acetate 1% Ointment, Lidocaine hydrochloride 0,05% with chlorhexidine
- Keywords
- Hydrocortisone, Lidocaine, Endotracheal tube, Neuromonitoring, Randomized controlled trial
- Medical subject headings
- Cough, Hoarseness, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone Acetate 1% OintmentDrug
Endotracheal tubes will be coated with 1% hydrocortisone acetate ointment prior to intubation. The ointment will be applied uniformly to the outer surface of the tube. This intervention aims to reduce postoperative throat inflammation and pain.
Lidocaine hydrochloride 0,05% with chlorhexidineDrug
Also called Cathejell
Endotracheal tubes will be treated with 0.05% lidocaine hydrochloride solution combined with chlorhexidine (Cathejell). The solution will be applied to the tube surface before intubation to provide local anesthesia and reduce postoperative throat discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone group | Experimental | Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness. Receives: Drug: Hydrocortisone Acetate 1% Ointment |
| Lidocaine group | Experimental | Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel). Receives: Drug: Lidocaine hydrochloride 0,05% with chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of severe throat pain at 24 hours post-operation
Proportion of patients scoring ≥3 points on the STONES throat pain subscale (0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain) assessed 24 hours after thyroid/parathyroid surgery. Evaluated through patient-reported questionnaire administered by a blinded investigator.
Measured: 24 hours post-operation
Frequency of clinically significant EMG signal reduction
Proportion of patients showing ≥50% decrease in amplitude of electromyographic (EMG) signals from recurrent laryngeal nerve during intraoperative neuromonitoring compared to baseline measurements (V1/ R1 timepoints), using the C2 neuromonitor system.
Measured: Perioperative/periprocedural
Secondary outcomes (4)
Frequency of intraoperative laryngeal reflexes (coughing)
Number of coughing episodes recorded by anesthesiologist during surgical procedure, graded as: 0 = no cough, 1 = single mild cough, 2 = persistent cough requiring intervention.
Measured: Perioperative/periprocedural
Episodes of complete EMG signal loss during surgery
Number of events with total loss of electromyographic response (OmV amplitude) during stimulation of recurrent laryngeal nerve, confirmed by repeated measurements at standard timepoints (V1/R1 to V2/R2).
Measured: Perioperative/periprocedural
Vocal cord mobility impairment (laryngoscopy)
Presence of unilateral/bilateral vocal cord paralysis or paresis detected through postoperative fiberoptic laryngoscopic examination, graded as: 0 = normal mobility, 1 = reduced mobility, 2 = complete paralysis."
Measured: 72 hours after surgery
Neck Disability Index (NDI) score
Patient-reported functional limitation score (0-50 scale) assessing neck pain impact on daily activities, with higher scores indicating greater disability. Collected through standardized questionnaire.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore Throat, Cough, HoarsenessStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Smooth Drug Development
- Responsible party
- Principal investigator, Efremov Sergey, Saint Petersburg State University, Russia
- Investigators
- Sergey M. Efremov, MD, PhD, Principal investigator, Saint Petersburg State University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124650
- Sponsor's protocol ID
- SPbU-STONES-2025
- Acronym
- STONES
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Row data may be shared by the reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07124650
- Acronym / sponsor ID
- STONES / SPbU-STONES-2025
- Keywords
- Hydrocortisone, Lidocaine, Endotracheal tube, Neuromonitoring, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Collaborators
- Smooth Drug Development
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
This randomized clinical trial aims to evaluate the effectiveness of two medications-hydrocortisone ointment and lidocaine solution-applied to the endotracheal tube in reducing postoperative throat pain, hoarseness, and cough following thyroid or parathyroid surgery with neuromonitoring.
A total of 764 adult patients undergoing elective neck surgery at Saint-Petersburg State University Hospital will be enrolled and randomly assigned to receive either a hydrocortisone-coated or lidocaine-coated endotracheal tube.
Outcomes will be assessed upon awakening from anesthesia, at 24 hours, and again at 3 days postoperatively.
The findings may contribute to improving postoperative comfort and recovery for patients undergoing similar surgical procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone group | Experimental | Drug: Hydrocortisone Acetate 1% OintmentParticipants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness. |
| Lidocaine group | Experimental | Drug: Lidocaine hydrochloride 0,05% with chlorhexidineParticipants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective open surgery on the thyroid/parathyroid glands with intraoperative neuromonitoring.
- Age ≥18 years.
- Willing and able to provide voluntary informed consent for participation in the study.
Key exclusion criteria (3 listed)
- Pregnancy (for women of childbearing potential).
- Known allergy to hydrocortisone or lidocaine.
- Refusal to participate in the study.
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 |
|---|---|---|
| Hydrocortisone Acetate 1% OintmentEndotracheal tubes will be coated with 1% hydrocortisone acetate ointment prior to intubation. The ointment will be applied uniformly to the outer surface of the tube. This intervention aims to reduce postoperative throat inflammation and pain. | Drug | Hydrocortisone group |
| Lidocaine hydrochloride 0,05% with chlorhexidineAlso: CathejellEndotracheal tubes will be treated with 0.05% lidocaine hydrochloride solution combined with chlorhexidine (Cathejell). The solution will be applied to the tube surface before intubation to provide local anesthesia and reduce postoperative throat discomfort. | Drug | Lidocaine group |
Primary outcome
Frequency of severe throat pain at 24 hours post-operation
Time frame: 24 hours post-operation
Proportion of patients scoring ≥3 points on the STONES throat pain subscale (0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain) assessed 24 hours after thyroid/parathyroid surgery. Evaluated through patient-reported questionnaire administered by a blinded investigator.
Frequency of clinically significant EMG signal reduction
Time frame: Perioperative/periprocedural
Proportion of patients showing ≥50% decrease in amplitude of electromyographic (EMG) signals from recurrent laryngeal nerve during intraoperative neuromonitoring compared to baseline measurements (V1/ R1 timepoints), using the C2 neuromonitor system.
4 secondary outcomes
Frequency of intraoperative laryngeal reflexes (coughing)
Time frame: Perioperative/periprocedural
Episodes of complete EMG signal loss during surgery
Time frame: Perioperative/periprocedural
Vocal cord mobility impairment (laryngoscopy)
Time frame: 72 hours after surgery
Neck Disability Index (NDI) score
Time frame: 3 days after surgery
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Row data may be shared by the reasonable request
Related trials for Postoperative Sore Throat, Cough, Hoarseness
Not yet recruitingObservational study
Effects of Video LMA Cuff Pressure in Tympanoplasty.
Oropharyngeal Leak Pressure, Airway Management
Not yet recruiting
Effect Of Intracuff Dexamethasone On Postoperative Sore Throat In Patients Undergoing Laparoscopic Cholecystectomy
Postoperative Sore Throat, Cough, Hoarseness
Recruiting
Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy
Appendicitis Acute, Postoperative Sore Throat, Cough, Hoarseness
Not yet recruiting
Effect of Cuff Pressure Assessment Methods on Postoperative Complications in Breast Surgery
Airway Complications, Postoperative Sore Throat
Active, not recruitingPhase 2/3
Air Versus Lignocaine for Endotracheal Tube Cuff Inflation and Effect on Postoperative Sore Throat and Intracuff Pressure
Postoperative Sore Throat, Cough, Hoarseness
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.
Sergey M. Efremov, MD, PhD principal investigator
Saint Petersburg State University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone Acetate 1% Ointment and Lidocaine hydrochloride 0,05% with chlorhexidine in people with Postoperative Sore Throat, Cough, Hoarseness and Thyroid and Parathyroid Surgery, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Russia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sergey M. Efremov, D. Med. Sc. (+79137946090, efremovsergm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of severe throat pain at 24 hours post-operation (time frame: 24 hours post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.