Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04991493
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2021-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Tramadol on Postoperative Sore Throat After General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The anesthesia provider will be blinded to the intervention group allocation. All patients will be blinded. The primary investigator will be blinded. The resident researcher who will be the outcome assessor will also be blinded. The care provider will be blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of Post-operative sore throat', 'timeFrame': '24 hours following extubation of endotracheal tube', 'description': 'The incidence of postoperative sore throat at 24 hours after extubation.'}], 'secondaryOutcomes': [{'measure': 'The Incidence of Post-operative sore throat', 'timeFrame': '30 Minutes following extubation of endotracheal tube', 'description': 'The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.'}, {'measure': 'The Incidence of Post-operative sore throat', 'timeFrame': '4 hours following extubation of endotracheal tube', 'description': 'The incidence of postoperative sore throat at 0 hours and 4 hours after extubation.'}, {'measure': 'The severity of Post-Operative Sore Throat', 'timeFrame': '30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube', 'description': 'Assessment of severity of postoperative sorethroat using scoring system, 0-No sore throat at any time since the extubation,1- Minimal sore throat,2- Moderate sore throat,3- Severe sore throat'}, {'measure': 'The incidence of of postoperative hoarseness.', 'timeFrame': '30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube', 'description': 'The incidence of of postoperative hoarseness at 0 hours，4 hours and 24 hours after extubation.'}, {'measure': 'The severity of postoperative hoarseness', 'timeFrame': '30 Minutes ，4 hours and 24 hours following extubation of endotracheal tube', 'description': 'Assessment of postoperative hoarseness using scoring system,0- No evidence of hoarseness at any time since the extubation,1-No evidence of hoarseness at the time of interview,2-Hoarseness at the time of interview noted by patient only, 3- Hoarseness that is easily noted at the time of interview'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tramadol', 'Post-operative Sore Throat', 'Intubation, Intratracheal', 'thyroid surgery'], 'conditions': ['Post-operative Sore Throat', 'Intubation Intratracheal', 'Thyroid Surgery']}, 'referencesModule': {'references': [{'pmid': '24124452', 'type': 'BACKGROUND', 'citation': 'Hu B, Bao R, Wang X, Liu S, Tao T, Xie Q, Yu X, Li J, Bo L, Deng X. The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. doi: 10.1371/journal.pone.0074467. eCollection 2013.'}, {'pmid': '27158989', 'type': 'BACKGROUND', 'citation': 'El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.'}, {'pmid': '23521170', 'type': 'BACKGROUND', 'citation': 'Tekelioglu UY, Apuhan T, Akkaya A, Demirhan A, Yildiz I, Simsek T, Gok U, Kocoglu H. Comparison of topical tramadol and ketamine in pain treatment after tonsillectomy. Paediatr Anaesth. 2013 Jun;23(6):496-501. doi: 10.1111/pan.12148. Epub 2013 Mar 23.'}, {'pmid': '22089326', 'type': 'BACKGROUND', 'citation': 'Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.'}]}, 'descriptionModule': {'briefSummary': 'Post operative sore throat after general anesthesia with endotracheal intubation is a common problem causing dissatisfaction and discomfort to the patients. The investigators want to study the effect of tramadol on postoperative sore throat in general anesthesia with endotracheal intubation.', 'detailedDescription': 'Design: A prospective, randomized, controlled study. Setting: Single-center university hospital. Participants: The study included 168 patients undergoing thyroid surgery under general anesthesia with endotracheal intubation.\n\nInterventions: The patients were allocated randomly into the following 3 groups: the control group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and another 5ml of normal saline was injected intravenously when the incision was washed and sutured；the pre-tramadol group: patients will be injected intravenously 5ml of tramadol (1mg / kg) 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured. the post-tramadol group: patients will be injected intravenously 5ml of normal saline 15 minutes before anesthesia and 5ml of tramadol (1mg / kg) was injected intravenously when the incision was washed and sutured. Postoperatively, all patients will receive standard treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Gender is one of the independent factors affecting postoperative sore throat. To reduce the bias from gender, we only considered female patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Female with American Society of Anesthesiologists (ASA) physical status I-II; Elective thyroidectomy(non-endoscopic) with endotracheal intubation; The patient signed the consent form.\n\nExclusion Criteria:\n\n\\- History of thyroid surgery A history of preoperative sore throat; Pregnancy; Retrosternal goiter; Thyroid tumor invading trachea need trachea reconstruction; Potentially difficult airway; Clinical diagnosis of chronic sore throat; Clinical diagnosis of psychosis; Tracheotomy after operation； Transfer to intensive care unit after operation； Contraindications to tramadol； Body mass index (BMI) \\> 30kg/m\\^2.'}, 'identificationModule': {'nctId': 'NCT04991493', 'briefTitle': 'Effect of Tramadol on Postoperative Sore Throat After General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Cancer Hospital of Shantou University Medical College'}, 'officialTitle': 'Effect of Tramadol on Postoperative Sore Throat in Thyroid Surgery Under General Anesthesia With Endotracheal Intubation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'QPOST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '5ml normal saline was injected intravenously 15 minutes before anesthesia and 5ml normal saline was injected intravenously when the incision was washed and sutured.', 'interventionNames': ['Other: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'pre-tramadol group', 'description': '5ml of tramadol containing 1mg / kg was injected intravenously 15 minutes before anesthesia and 5ml of normal saline was injected intravenously when the incision was washed and sutured.', 'interventionNames': ['Drug: Tramadol hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'post-tramadol group', 'description': '5ml of normal saline was injected intravenously 15 minutes before anesthesia and 5ml of tramadol containing 1mg / kg was injected intravenously when the incision was washed and sutured.', 'interventionNames': ['Drug: Tramadol hydrochloride']}], 'interventions': [{'name': 'Tramadol hydrochloride', 'type': 'DRUG', 'otherNames': ['Tramadol'], 'description': 'pre-tramadol group: 1mg/kg of tramadol will be intravenously injected 15 minutes before anesthesia.\n\npost-tramadol group: 1mg/kg of tramadol will be intravenously injected when the incision was washed and sutured.', 'armGroupLabels': ['post-tramadol group', 'pre-tramadol group']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'pre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured.\n\npost-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zegeng su, master', 'role': 'CONTACT', 'email': 'goctor@163.com', 'phone': '13929688978'}, {'name': 'xiang xu, master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Affiliated Cancer Hospital of Shantou University Medical College Medical', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}], 'centralContacts': [{'name': 'zegeng su, master', 'role': 'CONTACT', 'email': 'goctor@163.com', 'phone': '13929688978'}], 'overallOfficials': [{'name': 'zegeng su, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Cancer Hospital of Shantou University Medical College Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Cancer Hospital of Shantou University Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor/ Master of medicine', 'investigatorFullName': 'zegeng su', 'investigatorAffiliation': 'Affiliated Cancer Hospital of Shantou University Medical College'}}}}