Sore Throat After Open Neck Elective Surgery (STONES)

Saint Petersburg State University, Russia

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Sore Throat, Cough, Hoarseness; Thyroid and Parathyroid Surgery

Treatments: Drug: Hydrocortisone Acetate 1% Ointment; Drug: Lidocaine hydrochloride 0,05% with chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07124650

SPbU-STONES-2025

Details and patient eligibility

About

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.

Enrollment: 764 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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764 participants in 2 patient groups

Hydrocortisone group

Experimental group

Description:

Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness.

Treatment:

Drug: Hydrocortisone Acetate 1% Ointment

Lidocaine group

Experimental group

Description:

Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel).

Treatment:

Drug: Lidocaine hydrochloride 0,05% with chlorhexidine