Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-28 @ 8:23 PM
Study NCT ID:
NCT02092012
Status:
UNKNOWN
Last Update Posted:
2014-03-21
First Post:
2014-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'postoperative 1 day', 'description': 'Visual Analog Scale on rest and movement record'}], 'secondaryOutcomes': [{'measure': 'analgesic consumption', 'timeFrame': 'postoperative 1 day', 'description': 'morphine consumption with patient controlled analgesia record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'dexketoprofen trometamol', 'dexmedetomidine'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate comparison of preemptive analgesic effects of dexketoprofen versus dexmedetomidine on the patients that is undergoing abdominal hysterectomy.', 'detailedDescription': "Abdominal hysterectomy is associated with moderate to severe postoperative pain which has unfavorable effects on patient's recovery and procedure's outcome. Administration of opioid analgesics is routinely practiced but is limited with dose-related adverse effects.\\[1\\] Within this concept, combining an opioid with different analgesics acting by different mechanisms as multimodal analgesia is recommended for effective post-operative pain control Dexketoprofen trometamol is a newly developed, centrally acting NSAID with potency similar to that of μ-opioid agonists.\\[4\\] In a number of studies in different pain models, it has been proven to have a good analgesic efficacy and tolerability.\n\nDexmedetomidine is a highly selective α2 adrenoceptor agonist that provides sedation, analgesia, and sympatholysis. These characteristics make dexmedetomidine useful anesthetic adjunct during operation. Previous studies report that intravenous has a definitive role in postoperative analgesia through the reduction of opioid consumption The aim of this prospective randomized, double-blind study is to evaluate the analgesic efficacy and opioid sparing effects of preemptive single dose of dexketoprofen trometamol in comparison with dexmedetomidine in the patients abdominal hysterectomy , over a 24-hour (h) investigation period.\n\nAfter institutional approval and informed consent had been obtained, 60 patients scheduled for abdominal hysterectomy randomly allocated into two equal groups. Patients received ıv dexketoprofen 50 mg (Group I), ıv dexmedetomidine 1mcg/kg (Group II) after anesthesia induction and 10 minutes (min) before surgical incision. Patient controlled analgesia was supplied postoperatively using morphine. Hemodynamics, visual analogue scale (VAS), sedation score, morphine consumption, and side effects were recorded every and at 2, 6, 12 and 24 h after surgery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18- 65 year female\n* Scheduled for elective abdominal hysterectomy\n* No known allergies to drugs\n* ASA I-II patients\n\nExclusion Criteria:\n\n* Pregnancy\n* Drug or alcohol abuse\n* History of allergic reaction to any of the study drugs\n* Ongoing opioid, and non-steroidal anti-inflammatory\n* Analgesic therapy\n* Cardiac, respiratory, hepatic and/or renal failure\n* History of peptic ulcer disease'}, 'identificationModule': {'nctId': 'NCT02092012', 'briefTitle': 'Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on Abdominal Hysterectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Comparison of Preemptive Analgesic Effects of Dexketoprofen Versus Dexmedetomidine on the Patients That is Undergoing Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': '2013/489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexketoprofen trometamol', 'description': 'ıv 50 mg dexketoprofen trometamol after anesthesia induction', 'interventionNames': ['Drug: dexketoprofen trometamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': 'ıv 1 mcg/kg dexmedetomidine after anaesthesia induction', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'dexketoprofen trometamol', 'type': 'DRUG', 'otherNames': ['arveles'], 'description': 'ıv 50 mg dexketoprofen trometamol after anaesthesia induction', 'armGroupLabels': ['dexketoprofen trometamol']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'ıv 1 mcg/kg dexmedetomidine after anaesthesia induction', 'armGroupLabels': ['dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'selda kayaaltı, resident', 'role': 'CONTACT', 'email': 'drselda@hotmail.com', 'phone': '+905558168918'}, {'name': 'fatih ugur, assoc', 'role': 'CONTACT', 'email': 'ugurf@erciyes.edu.tr', 'phone': '+905359730073'}], 'facility': 'Erciyes Univercity Medicine Faculty', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'selda kayaaltı, resident', 'role': 'CONTACT', 'email': 'drselda@hotmail.com', 'phone': '+905558168918'}, {'name': 'fatih ugur, assoc', 'role': 'CONTACT', 'email': 'ugurf@erciyes.edu.tr', 'phone': '+905359730073'}], 'overallOfficials': [{'name': 'selda kayaaltı, resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'erciyes univercity medicine faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'SELDA KAYAALTI, MD', 'investigatorAffiliation': 'TC Erciyes University'}}}}