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Sore Throat After Open Neck Elective Surgery

NCT07124650 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 764

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

Hydrocortisone Acetate 1% Ointment

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.

DRUG

Lidocaine hydrochloride 0,05% with chlorhexidine

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.

Sponsors & Collaborators

  • Smooth Drug Development

    collaborator UNKNOWN

  • Saint Petersburg State University, Russia

    lead OTHER

Principal Investigators

  • Sergey M. Efremov, MD, PhD · Saint Petersburg State University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124650 on ClinicalTrials.gov