Sore Throat After Open Neck Elective Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydrocortisone Acetate 1% Ointment, Lidocaine hydrochloride 0,05% with chlorhexidine.
- Who it may be relevant to
- Registry conditions: Postoperative Sore Throat, Cough, Hoarseness, Thyroid and Parathyroid Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Hydrocortisone Acetate 1% Ointment
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. - Drug Lidocaine 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.
Primary outcome measures
- Frequency of severe throat pain at 24 hours post-operation [Time frame: 24 hours post-operation]
- Frequency of clinically significant EMG signal reduction [Time frame: Perioperative/periprocedural]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Russia · 1 center
- Saint Petersburg State University Hospital — Saint Petersburg
Identifiers
NCT: NCT07124650 · SPbU-STONES-2025