Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
764 participants
INTERVENTIONAL
2025-09-15
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Hydrocortisone group
Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness.
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.
Lidocaine group
Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel).
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ā„18 years.
* Willing and able to provide voluntary informed consent for participation in the study.
Exclusion Criteria
* Known allergy to hydrocortisone or lidocaine.
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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Smooth Drug Development
UNKNOWN
Saint Petersburg State University, Russia
OTHER
Responsible Party
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Efremov Sergey
Deputy director for science, Saint-Petersburg state university hospital
Principal Investigators
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Sergey M. Efremov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Saint Petersburg State University Hospital
Locations
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Saint Petersburg State University Hospital
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPbU-STONES-2025
Identifier Type: -
Identifier Source: org_study_id
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