Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT05905757
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative non invasive blood pressure', 'timeFrame': '10 minutes', 'description': 'non invasive blood pressure(systolic, diastolic and mean blood pressure)'}, {'measure': 'intraoperative opioid consumption', 'timeFrame': '40 minutes', 'description': 'The necessary opioid (mcg) addiction was noted'}, {'measure': 'intraoperative muscle relaxant use', 'timeFrame': '40 minutes', 'description': 'The necessary muscle relaxant (mg) addiction was noted'}, {'measure': 'intraoperative heart rate', 'timeFrame': '5 minutes', 'description': 'Heart rate was noted'}], 'secondaryOutcomes': [{'measure': 'postoperative analgesic effects', 'timeFrame': '0., 3., 6. hour measurements were evaluated', 'description': 'Visual analogue scale (VAS) scores were noted.pointed between 0-10. 0:No pain, 5-6-7:medium pain, 9-10:unbearable pain'}, {'measure': 'Number of participants with postoperative side effects', 'timeFrame': '0., 3., 6. hour measurements were evaluated', 'description': 'nausea, vomiting, chills. Patients with these effects were noted. Evaluated by the number of people'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transversus abdominis plane block', 'adjuvant', 'Dexmedetomidine', 'Tramadol'], 'conditions': ['Transversus Abdominis Plane Block']}, 'referencesModule': {'references': [{'pmid': '38002616', 'type': 'DERIVED', 'citation': 'Korkutata Z, Tekeli AE, Kurt N. Intraoperative and Postoperative Effects of Dexmedetomidine and Tramadol Added as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block. J Clin Med. 2023 Nov 9;12(22):7001. doi: 10.3390/jcm12227001.'}]}, 'descriptionModule': {'briefSummary': 'In this study, dexmedetomidine and tramadol were added as adjuvant to bupivacaine in transversus abdominis plane block (TAP), intraoperative hemodynamics, opioid consumption, muscle relaxant use, postoperative analgesic effects and side effects (such as nausea-vomiting) were evaluated.', 'detailedDescription': 'The study was carried out with 60 ASA I-II class participants aged 20-60 years who underwent laparoscopic cholecystectomy at Van Yuzuncu Yıl University Faculty of Medicine. Preoperative evaluation was made before the operation, routine laboratory analyzes were taken, the participants were informed about the study, and their written consent was obtained. Participants were randomized into two groups.\n\n* Group T (Adjuvant Tramadol): 40 mL of 0.250% bupivacaine + 1.5mg/kg and a maximum of 100 mg tramadol adjuvant\n* Group D (Adjuvant Dexmedetomidine): 40 mL of 0.250% bupivacaine + 0.5 mcg/kg and a maximum of 50 mcg dexmedetomidine adjuvant Standard general anesthesia was applied. After intubation, bilateral subcostal TAP block was performed by the same anesthesiologist, demographic data were recorded. Intraoperative vital signs of the participants (pulse, non-invasive blood pressure and peripheral oxygen saturation measurement), additional opioid and muscle relaxant needs, and complications were recorded. Extubation was performed after standard decurarization with atropine and neostigmine. Postoperative side effects (nausea, vomiting, pruritus, shivering), postoperative additional analgesic need, and 0 hour (Modified aldrete score ≥9 time was accepted as 0 hour), 3rd hour and 6th hour Visual Analogue Scale (VAS) scores were evaluated and recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-60 years old\n* Those who will undergo elective laparoscopic cholecystectomy surgery\n* Those in ASA I-II physical status\n* Those who gave consent to participate in the study\n\nExclusion Criteria:\n\n* Those outside the age range of 20-60\n* Those outside of ASA I-II physical status\n* Serious heart, lung, liver disease\n* Kidney failure\n* Bleeding diathesis\n* Those who develop complications during the procedure\n* Those with fever, active infection\n* Those who are allergic to the drugs to be used\n* Those who refused to participate in the study\n* Those with hypothermic and acid-base disorders\n* Electrolyte disturbances such as hypokalemia, hypocalcemia\n* Those taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors\n* Pregnant\n* Those with bleeding\n* BMI 30 and above'}, 'identificationModule': {'nctId': 'NCT05905757', 'briefTitle': 'Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Intraoperative and Postoperative Effects of Adjuvant Dexmedetomidine and Tramadol in Subcostal Transversus Abdominis Plan Block', 'orgStudyIdInfo': {'id': '2023/2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group T', 'description': 'Group T (Adjuvant tramadol): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 40 mL adjuvant 1.5mg/kg (maximum 100 mg) tramadol.\n\nSystolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2 values were recorded.\n\nDemographic data of the patients \\[age, weight, height, body mass index (BMI), smoking use\\] and operation times were recorded.\n\nAll patients were administered 1000 mg parol IV as standard analgesic before extubation.\n\nThe patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.The patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment.', 'interventionNames': ['Drug: Tramadol + Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'Group D (adjuvant dexmedetomidine): Bilateral subcostal TAP block was performed using solutions prepared by adding 0.250% bupivacaine + 0.5 mcg/kg and (maximum 50 mcg) dexmedetomidine.\n\nAll patients were administered 1000 mg parol IV as standard analgesic before extubation.\n\nThe patients were followed up for side effects (such as nausea-vomiting, chills, itching and desaturation) including drug allergies.\n\nThe patients were evaluated at 0, 3 and 6 hours after the operation with a 0-10 verbal rating scale visual analog scale (VAS) and the data were recorded. VAS 0-2: no pain, 3-4: mild pain, 5-6: moderate pain, 7-8: severe pain, 9-10: excruciating pain. Additional analgesic requirement in the postoperative period was calculated by measuring VAS\\>4 values. In all groups, VAS˃ 4 value was evaluated in favor of analgesic need and 50 mg Dexketoprofen IV bolus was administered in accordance with conventional treatment.', 'interventionNames': ['Procedure: Dexmedetomidin + bupivacaine']}], 'interventions': [{'name': 'Dexmedetomidin + bupivacaine', 'type': 'PROCEDURE', 'description': 'dexmedetomidine was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)', 'armGroupLabels': ['Group D']}, {'name': 'Tramadol + Bupivacaine', 'type': 'DRUG', 'description': 'tramadol was added as adjuvant to bupivacaine in transversus abdominis plane block (TAP)', 'armGroupLabels': ['Group T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65100', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yuzuncu Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'overallOfficials': [{'name': 'School of Medicine Department of Anesthesiology and Reanimation', 'role': 'STUDY_CHAIR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arzu Esen Tekeli', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}