Sore Throat After Open Neck Elective Surgery

NCT07124650 | Recruiting Phase 4 DMC

• 1 other identifier: SPbU-STONES-2025
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hydrocortisone; Lidocaine; Endotracheal tube; Neuromonitoring; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Frequency of severe throat pain at 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.

  24 hours post-operation

• Frequency of clinically significant EMG signal reduction

  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.

  Perioperative/periprocedural

Secondary Outcomes (4)

• Frequency of intraoperative laryngeal reflexes (coughing)

  Perioperative/periprocedural

• Episodes of complete EMG signal loss during surgery

  Perioperative/periprocedural

• Vocal cord mobility impairment (laryngoscopy)

  72 hours after surgery

• Neck Disability Index (NDI) score

  3 days after surgery

Study Arms (2)

Hydrocortisone group

EXPERIMENTAL

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

Drug: Hydrocortisone Acetate 1% Ointment

Lidocaine group

EXPERIMENTAL

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

Drug: Lidocaine hydrochloride 0,05% with chlorhexidine

Interventions

Hydrocortisone Acetate 1% Ointment DRUG

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.

Hydrocortisone group

Lidocaine hydrochloride 0,05% with chlorhexidine DRUG

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.

Also known as: Cathejell

Lidocaine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy (for women of childbearing potential).
• Known allergy to hydrocortisone or lidocaine.
• Refusal to participate in the study.

Sponsors & Collaborators

• Smooth Drug Development: collaborator
• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint Petersburg State University Hospital

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Cough; Hoarseness; Thyroid Diseases

Interventions

hydrocortisone acetate; Ointments; Chlorhexidine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sergey M. Efremov, MD, PhD

  Saint Petersburg State University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey M. Efremov, D. Med. Sc.

CONTACT

+79137946090; efremovsergm@gmail.com

Alexey Y. Kulikov, Ph. D. (Med.)

CONTACT

+79217896909; alexeykulikov1987@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director for science, Saint-Petersburg state university hospital

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

RU (1)