Health TrialsbyHealthPanel

Sore Throat After Open Neck Elective Surgery

ConditionsPostoperative Sore Throat, Cough, HoarsenessThyroid and Parathyroid Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy (for women of childbearing potential).

Known allergy to hydrocortisone or lidocaine.

Refusal to participate in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

764 Participants
are divided into 2 treatment groups
Group A: Hydrocortisone groupExperimental treatment 1 intervention
Group B: Lidocaine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours post-operation
2

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.

Time frame
Perioperative/periprocedural

Secondary outcomes

1

Frequency of intraoperative laryngeal reflexes (coughing)

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

Time frame
Perioperative/periprocedural
2

Episodes of complete EMG signal loss during surgery

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).

Time frame
Perioperative/periprocedural
3

Vocal cord mobility impairment (laryngoscopy)

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."

Time frame
72 hours after surgery
4

Neck Disability Index (NDI) score

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.

Time frame
3 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saint Petersburg State University, Russia

Lead sponsor

Smooth Drug Development

Collaborator

Source ClinicalTrials.gov
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