Reducing sore throat after thyroid or parathyroid surgery
Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial
This test will try whether coating the breathing tube with hydrocortisone ointment or lidocaine solution reduces throat pain, hoarseness, and cough in adults having elective thyroid or parathyroid surgery with neuromonitoring.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 764 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT07124650 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center trial will enroll 764 adults undergoing elective open thyroid or parathyroid surgery with intraoperative neuromonitoring and randomly assign them to receive an endotracheal tube coated with either hydrocortisone 1% ointment or lidocaine 0.05% with chlorhexidine. The coated tube will be used during standard anesthesia and surgery, and patients will be monitored per routine clinical care. Outcomes — throat pain, hoarseness, and cough — will be measured on awakening, at 24 hours, and at 3 days postoperatively. Results aim to inform simple, low-cost measures to improve early postoperative comfort after these procedures.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective open thyroid or parathyroid surgery with intraoperative neuromonitoring who can give informed consent and do not have allergies to the study drugs.
Not a fit: Patients who are pregnant, allergic to hydrocortisone or lidocaine, children, or those undergoing emergency or non-neck surgeries are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the coating could reduce immediate postoperative throat pain, hoarseness, and coughing, improving patient comfort and early recovery.
How similar studies have performed: Previous randomized trials and meta-analyses have shown that topical corticosteroids or lidocaine on endotracheal tubes can reduce postoperative sore throat and hoarseness, though lidocaine results have been mixed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Petersburg
- Saint Petersburg State University Hospital — Saint Petersburg, Russia (Recruiting)
Study contacts
- Principal investigator: Sergey M. Efremov, MD, PhD — Saint Petersburg State University Hospital
- Study coordinator: Sergey M. Efremov, D. Med. Sc.
- Email: efremovsergm@gmail.com
- Phone: +79137946090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.