Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT07124650
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sore Throat After Open Neck Elective Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D006685', 'term': 'Hoarseness'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C021650', 'term': 'hydrocortisone acetate'}, {'id': 'D009824', 'term': 'Ointments'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 764}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of severe throat pain at 24 hours post-operation', 'timeFrame': '24 hours post-operation', 'description': '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.'}, {'measure': 'Frequency of clinically significant EMG signal reduction', 'timeFrame': 'Perioperative/periprocedural', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Frequency of intraoperative laryngeal reflexes (coughing)', 'timeFrame': 'Perioperative/periprocedural', 'description': 'Number of coughing episodes recorded by anesthesiologist during surgical procedure, graded as: 0 = no cough, 1 = single mild cough, 2 = persistent cough requiring intervention.'}, {'measure': 'Episodes of complete EMG signal loss during surgery', 'timeFrame': 'Perioperative/periprocedural', 'description': '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).'}, {'measure': 'Vocal cord mobility impairment (laryngoscopy)', 'timeFrame': '72 hours after surgery', 'description': '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."'}, {'measure': 'Neck Disability Index (NDI) score', 'timeFrame': '3 days after surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydrocortisone', 'Lidocaine', 'Endotracheal tube', 'Neuromonitoring', 'Randomized controlled trial'], 'conditions': ['Postoperative Sore Throat, Cough, Hoarseness', 'Thyroid and Parathyroid Surgery']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind 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.\n\nA 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.\n\nOutcomes will be assessed upon awakening from anesthesia, at 24 hours, and again at 3 days postoperatively.\n\nThe findings may contribute to improving postoperative comfort and recovery for patients undergoing similar surgical procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective open surgery on the thyroid/parathyroid glands with intraoperative neuromonitoring.\n* Age ≥18 years.\n* Willing and able to provide voluntary informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Pregnancy (for women of childbearing potential).\n* Known allergy to hydrocortisone or lidocaine.\n* Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07124650', 'acronym': 'STONES', 'briefTitle': 'Sore Throat After Open Neck Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'Effect of Hydrocortisone and Lidocaine on Endotracheal Tube for Sore Throat and Hoarseness After Thyroid/Parathyroid Surgery With Neuromonitoring: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SPbU-STONES-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrocortisone group', 'description': 'Participants receive endotracheal tubes coated with 1% hydrocortisone ointment to reduce postoperative sore throat and hoarseness.', 'interventionNames': ['Drug: Hydrocortisone Acetate 1% Ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Participants receive endotracheal tubes coated with 0.05% lidocaine and chlorhexidine solution (Cathelgel).', 'interventionNames': ['Drug: Lidocaine hydrochloride 0,05% with chlorhexidine']}], 'interventions': [{'name': 'Hydrocortisone Acetate 1% Ointment', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Hydrocortisone group']}, {'name': 'Lidocaine hydrochloride 0,05% with chlorhexidine', 'type': 'DRUG', 'otherNames': ['Cathejell'], 'description': '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.', 'armGroupLabels': ['Lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Sergey Efremov', 'role': 'CONTACT', 'email': 'efremovsergm@gmail.com', 'phone': '79137946090'}], 'facility': 'Saint Petersburg State University Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Sergey M. Efremov, D. Med. Sc.', 'role': 'CONTACT', 'email': 'efremovsergm@gmail.com', 'phone': '+79137946090'}, {'name': 'Alexey Y. Kulikov, Ph. D. (Med.)', 'role': 'CONTACT', 'email': 'alexeykulikov1987@yandex.ru', 'phone': '+79217896909'}], 'overallOfficials': [{'name': 'Sergey M. Efremov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Petersburg State University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Row data may be shared by the reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Smooth Drug Development', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director for science, Saint-Petersburg state university hospital', 'investigatorFullName': 'Efremov Sergey', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}