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NCT Number: NCT07124650

Sore Throat After Open Neck Elective Surgery

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.

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Key information

Conditions

Postoperative Sore Throat, Cough, Hoarseness Cough Endocrine System Diseases Hoarseness Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Thyroid Diseases Thyroid and Parathyroid Surgery Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saint Petersburg State University Hospital

Saint Petersburg, Russia

Location status: Recruiting

Location contact

Sergey Efremov

CONTACT

[email protected]

79137946090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Other names: Cathejell

Primary outcomes

  1. Frequency of severe throat pain at 24 hours post-operation

    Time frame: 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.

  2. Frequency of clinically significant EMG signal reduction

    Time frame: Perioperative/periprocedural

    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.

Secondary outcomes

  1. Frequency of intraoperative laryngeal reflexes (coughing)

    Time frame: Perioperative/periprocedural

    Number of coughing episodes recorded by anesthesiologist during surgical procedure, graded as: 0 = no cough, 1 = single mild cough, 2 = persistent cough requiring intervention.

  2. Episodes of complete EMG signal loss during surgery

    Time frame: Perioperative/periprocedural

    Number of events with total loss of electromyographic response (OmV amplitude) during stimulation of recurrent laryngeal nerve, confirmed by repeated measurements at standard timepoints (V1/R1 to V2/R2).

  3. Vocal cord mobility impairment (laryngoscopy)

    Time frame: 72 hours after surgery

    Presence of unilateral/bilateral vocal cord paralysis or paresis detected through postoperative fiberoptic laryngoscopic examination, graded as: 0 = normal mobility, 1 = reduced mobility, 2 = complete paralysis."

  4. Neck Disability Index (NDI) score

    Time frame: 3 days after surgery

    Patient-reported functional limitation score (0-50 scale) assessing neck pain impact on daily activities, with higher scores indicating greater disability. Collected through standardized questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+79217896909

Sergey M. Efremov, D. Med. Sc.

CONTACT

[email protected]

+79137946090

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Collaborators

  • Smooth Drug Development

Registry information

Official study title

Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial

Acronym: STONES

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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