Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT07064993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative and Postoperative Effects of Tramadol and Dexamethasone Added to Washing Solution in Knee Arthroscopies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D023341', 'term': 'Chills'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomised, controlled, double-blind,'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-07-13', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain measurement', 'timeFrame': '3 hours interval', 'description': 'Visual Analogue Scale scores (0 to 10, 0:no pain, 10 worst)'}], 'secondaryOutcomes': [{'measure': 'ıntraoperative and post operative effects except VAS scores', 'timeFrame': '3 hours interval', 'description': 'Non invasive blood pressure (mmHg),'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee arthroscopy', 'analgesia', 'general anesthesia'], 'conditions': ['Nausea and Vomitting', 'VAS Will be Used to Assess Pain Postoperative', 'Itching', 'Chills']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of tramadol and dexamethasone added to washing solutions on postoperative nausea and vomiting, VAS score, itching and chills in knee arthroscopy cases.\n\nRandomised, double-blind, prospective, clinical trial\n\nResearch Question(s):\n\n1. Do tramadol and dexamethasone added to the washing solution have any effect on postoperative parameters in knee arthroscopy cases?\n2. Does the postoperative efficacy change depending on the dose of tramadol and dexamethasone in the washing solution?\n\nTranslated with DeepL.com (free version)', 'detailedDescription': 'Knee arthroscopy is a minimal surgical treatment method that allows closed intervention under anaesthesia for the diagnosis and treatment of joint disorders. The natural structure of the joints is preserved as much as possible and no unnecessary tissue damage is caused. The most important advantage is the possibility to reach every part of the joint and provide complete treatment.The aim of the study was to evaluate the effects of tramadol and dexamethasone added to washing solutions on postoperative nausea and vomiting, VAS score, itching and chills in knee arthroscopy cases.\n\nPatients who are decided to undergo knee arthroscopy will be evaluated preoperatively by the anaesthesia outpatient clinic. Necessary information will be given and consent will be obtained. Patients will be randomised into 2 groups as study (S) and control (C) groups.\n\nStudy Group (Group S): 100 mg tramadol + 8 mg dexamethasone will be added to each 1000cc washing solution.\n\n(tramadol max iv dose: 400 mg/day) (Dexamethasone max iv dose: 32mg/day) No any drugs will be used for control group solution For postoperative analgesia, 15mg/kg paracetamol iv will be administered to both groups as standard before extubation. The moment of being admitted to the PACU and having a RAMSAY sedation scale of 3 or less will be accepted as hour 0; 0, 3 and 6 hours VAS, nausea, vomiting, itching and chills will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All elective arthroscopy cases performed under general anaesthesia\n* ASA 1-2 status\n* Patients giving written consent\n\nExclusion Criteria:\n\n* ASA 3 and above status\n* Pregnant\n* Cases with advanced hepatic and renal insufficiency\n* Cases with bleeding diathesis\n* Cases with BMI\\>35\n* Cases requiring regional anaesthesia'}, 'identificationModule': {'nctId': 'NCT07064993', 'briefTitle': 'Intraoperative and Postoperative Effects of Tramadol and Dexamethasone Added to Washing Solution in Knee Arthroscopies', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Intraoperative and Postoperative Effects of Tramadol and Dexamethasone Added to Washing Solution in Knee Arthroscopies', 'orgStudyIdInfo': {'id': '19.11.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standart knee arthroscopy washing solution was used. No drugs administered', 'interventionNames': ['Other: Observation']}, {'type': 'EXPERIMENTAL', 'label': 'study group', 'description': '100 mg tramadol + 8 mg dexamethasone will be added to each 1000cc washing solution of the patients in the study group. (tramadol max i.v dose: 400 mg/day) dexamethasone max i.v dose: 32 mg/day)', 'interventionNames': ['Procedure: Experimental']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Routine monitoring and observation', 'armGroupLabels': ['Control group']}, {'name': 'Experimental', 'type': 'PROCEDURE', 'description': 'Administration of tramadol and dexmethasone to arthroscopy solution', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'Şükran Sevimli, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Van Yuzuncu Yil University Ethics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Personal data of the participants will be protected'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Arzu Esen Tekeli', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}