Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-08 @ 10:56 PM
Study NCT ID:
NCT06274333
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D000082', 'term': 'Acetaminophen'}], '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': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-02-07', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of catheter-related bladder discomfort (CRBD)', 'timeFrame': '24 hours postoperative', 'description': 'The incidence of catheter-related bladder discomfort (CRBD) will be assessed at 30 minutes and 1, 2, 4, 6,8,10,12 and 24 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours postoperatively', 'description': 'Postoperative pain will be assessed with the Visual Analog Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)'}, {'measure': 'Meperidine requirement', 'timeFrame': '24 hours postoperatively', 'description': 'Total amount of consumed meperidine will be documented'}, {'measure': 'Patient satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Patients\' satisfaction was measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.'}, {'measure': 'Surgeon satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Surgeon\' satisfaction was measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Nephrolithotripsy (PCNL)']}, 'descriptionModule': {'briefSummary': 'The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 20 - 50 years\n* ASA (The American Society of Anesthesiologists) I or II,\n* undergo percutaneous nephrolithotomy (PCNL)\n\nExclusion Criteria:\n\n* Patients with history of psychotic illnesses\n* Opioid users\n* Bladder obstruction,\n* Benign prostatic hyperplasia\n* Overactive bladder (OAB) defined as frequency \\_3 times at night or \\_8 times within 24 hours.'}, 'identificationModule': {'nctId': 'NCT06274333', 'briefTitle': 'Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'RC.18.1.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DP group', 'description': 'Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg', 'interventionNames': ['Drug: Dexmedetomidine 0.5 mic/kg', 'Drug: Paracetamol 10mg/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TP group', 'description': 'Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.', 'interventionNames': ['Drug: Tramadol 1mg/kg', 'Drug: Paracetamol 10mg/kg']}], 'interventions': [{'name': 'Dexmedetomidine 0.5 mic/kg', 'type': 'DRUG', 'description': 'Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,', 'armGroupLabels': ['DP group']}, {'name': 'Tramadol 1mg/kg', 'type': 'DRUG', 'description': 'Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.', 'armGroupLabels': ['TP group']}, {'name': 'Paracetamol 10mg/kg', 'type': 'DRUG', 'description': 'Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg. Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.', 'armGroupLabels': ['DP group', 'TP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Neveen Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201069482380'}, {'name': 'Hany Bauiomy, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed M. Abosakaya, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neveen Kohaf', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data will be available upon reasonable request from corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Benha University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Neveen Abd El Maksoad Kohaf', 'investigatorAffiliation': 'Al-Azhar University'}}}}