Postoperative Sore Throat, Cough, Hoarseness, Thyroid and Parathyroid Surgery
Conditions
Keywords
Hydrocortisone, Lidocaine, Endotracheal tube, Neuromonitoring, Randomized controlled trial
Brief summary
This randomized, double-blind 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.
Interventions
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.
DRUGLidocaine hydrochloride 0,05% with chlorhexidine
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.
Sponsors
Smooth Drug Development
Saint Petersburg State University, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Pregnancy (for women of childbearing potential). * Known allergy to hydrocortisone or lidocaine. * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of severe throat pain at 24 hours post-operation | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of intraoperative laryngeal reflexes (coughing) | Perioperative/periprocedural | Number of coughing episodes recorded by anesthesiologist during surgical procedure, graded as: 0 = no cough, 1 = single mild cough, 2 = persistent cough requiring intervention. |
| Episodes of complete EMG signal loss during surgery | Perioperative/periprocedural | 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). |
| Vocal cord mobility impairment (laryngoscopy) | 72 hours after surgery | 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. |
| Neck Disability Index (NDI) score | 3 days after surgery | 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. |
Countries
Russia
Contacts
Primary ContactSergey M. Efremov, D. Med. Sc.
Backup ContactAlexey Y. Kulikov, Ph. D. (Med.)
Outcome results
None listed