A Phase 4 interventional study of Hydrocortisone Acetate 1% Ointment and Lidocaine hydrochloride 0,05% with chlorhexidine in Postoperative Sore Throat, Cough, Hoarseness and Thyroid and Parathyroid Surgery, sponsored by Saint Petersburg State University, Russia. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Saint Petersburg State University, Russia · Phase 4, Interventional, and Prevention
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 764 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Saint Petersburg State University, Russia is the lead sponsor of 34 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness.
Drug: Hydrocortisone Acetate 1% Ointment
Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel).
Drug: Lidocaine hydrochloride 0,05% with chlorhexidine
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.
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.
Also known as: Cathejell
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.
Time frame: 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.
Time frame: Perioperative/periprocedural
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.
Time frame: 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).
Time frame: 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."
Time frame: 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.
Time frame: 3 days after surgery
Plan to share: Yes — Row data may be shared by the reasonable request
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hydrocortisone acetate
Saint Petersburg State University, Russia