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| Name | Class |
|---|---|
| Smooth Drug Development | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone group | Experimental | Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness. |
|
| Lidocaine group | Experimental | Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone Acetate 1% Ointment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Perioperative/periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperative/periprocedural |
| Episodes of complete EMG signal loss during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey M. Efremov, D. Med. Sc. | Contact | +79137946090 | efremovsergm@gmail.com | |
| Alexey Y. Kulikov, Ph. D. (Med.) | Contact | +79217896909 | alexeykulikov1987@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey M. Efremov, MD, PhD | Saint Petersburg State University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Petersburg State University Hospital | Recruiting | Saint Petersburg | Russia |
Row data may be shared by the reasonable request
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| ID | Term |
|---|---|
| D003371 | Cough |
| D006685 | Hoarseness |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C021650 | hydrocortisone acetate |
| D009824 | Ointments |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
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| Lidocaine hydrochloride 0,05% with chlorhexidine | Drug | 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. |
|
|
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). |
| 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." | 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. | 3 days after surgery |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000578 |
| Amidines |
| D009930 | Organic Chemicals |