NCT07124650 Sore Throat After Open Neck Elective Surgery
| NCT ID | NCT07124650 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | Postoperative Sore Throat, Cough, Hoarseness |
| Study Type | INTERVENTIONAL |
| Enrollment | 764 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 764 participants in total. It began in 2025-09-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Sergey M. Efremov, MD, PhD
PRINCIPAL INVESTIGATOR
Saint Petersburg State University Hospital
Frequently Asked Questions
Who can join the NCT07124650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Sore Throat, Cough, Hoarseness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124650 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07124650 currently recruiting?
Yes, NCT07124650 is actively recruiting participants. Contact the research team at efremovsergm@gmail.com for enrollment information.
Where is the NCT07124650 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT07124650 clinical trial?
NCT07124650 is sponsored by Saint Petersburg State University, Russia. The principal investigator is Sergey M. Efremov, MD, PhD at Saint Petersburg State University Hospital. The trial plans to enroll 764 participants.