Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:46 AM
Study NCT ID:
NCT07445451
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an interventional study with a parallel assignment model. Participants are randomly assigned to one of three groups (Magnesium Sulfate, Dexmedetomidine, or Control), and each group is observed independently and concurrently. The study is single-blind, meaning that the investigators and the statistician analyzing the data are unaware of the assigned infusion type, while participants do not know which group they are in. The primary purpose of the study is treatment, aiming to evaluate the intraoperative effects of magnesium sulfate and dexmedetomidine on postoperative analgesia, hemodynamic stability, and respiratory function.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Analgesic Request', 'timeFrame': 'Postoperative period up to 24 hours', 'description': 'Time (in minutes) from the end of surgery until the patient first requests postoperative analgesia.'}, {'measure': 'Total Postoperative Analgesic Consumption', 'timeFrame': '24 hours postoperative', 'description': 'Total amount of analgesics (paracetamol and tramadol) administered within 24 hours after surgery.'}, {'measure': 'Postoperative Pain Scores', 'timeFrame': '24 hours postoperative', 'description': 'Pain intensity measured using the Visual Analog Scale (VAS) at the end of surgery, 60 minutes, 6 hours, and 24 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Integrated Pulmonary Index (IPI)', 'timeFrame': 'During surgery', 'description': 'Respiratory effort and ventilatory adequacy measured intraoperatively.'}, {'measure': 'Intraoperative heart rate', 'timeFrame': 'During surgery', 'description': 'Heart rate will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative heart rate will be recorded and reported in beats per minute (bpm).'}, {'measure': 'Intraoperative systolic blood pressure', 'timeFrame': 'During surgery', 'description': 'Systolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative systolic blood pressure will be recorded and reported in millimeters of mercury (mmHg).'}, {'measure': 'Intraoperative diastolic blood pressure', 'timeFrame': 'During surgery', 'description': 'Diastolic blood pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative diastolic blood pressure will be recorded and reported in millimeters of mercury (mmHg).'}, {'measure': 'Intraoperative mean arterial pressure', 'timeFrame': 'During surgery', 'description': 'Mean arterial pressure will be continuously monitored intraoperatively using standard anesthesia monitoring. Mean intraoperative MAP values will be recorded and reported in millimeters of mercury (mmHg).'}, {'measure': 'Adverse Effects', 'timeFrame': 'Intraoperative and 24 hours postoperative', 'description': 'Incidence of hypotension, bradycardia, desaturation, postoperative nausea and vomiting, and other side effects.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative analgesia', 'Integrated Pulmonary Index', 'TURBT'], 'conditions': ['Bladder Tumors', 'Spinal Anesthesia', 'Postoperative Pain', 'Magnesium Sulfate', 'Dexmedetomidine', 'Hemodynamic and Respiratory Monitoring']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluated the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine on postoperative pain, analgesic consumption, hemodynamic stability, and respiratory function in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Magnesium sulfate significantly reduced postoperative pain scores, delayed the time to first analgesic request, and decreased total analgesic consumption compared to dexmedetomidine and control groups, while both agents were hemodynamically and respiratorily safe.', 'detailedDescription': 'This study is a prospective, randomized, controlled trial designed to evaluate the effects of intraoperative intravenous magnesium sulfate versus dexmedetomidine infusions in patients undergoing elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia. Adult patients (age 18-85 years) with ASA physical status I-III scheduled for TUR-M were enrolled. Participants were randomly assigned to receive either magnesium sulfate, dexmedetomidine, or saline infusion during surgery. All patients received standardized spinal anesthesia. The study assesses postoperative pain, analgesic consumption, hemodynamic and respiratory parameters, and side effects. The trial aims to determine which agent provides better postoperative analgesia while maintaining cardiovascular and respiratory safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge between 18 and 85 years. Classified as ASA physical status I, II, or III according to the American Society of Anesthesiologists.\n\nPatients scheduled for elective transurethral resection of bladder tumor (TUR-M) under spinal anesthesia.\n\nExclusion Criteria:\n\nPatients under 18 years or over 85 years of age. Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy).\n\nHistory or current diagnosis of significant cardiac arrhythmia. Known allergy or contraindication to the study drugs (magnesium sulfate or dexmedetomidine).\n\nPatients requiring conversion to general anesthesia due to inadequate spinal anesthesia intraoperatively.\n\nMental retardation, cognitive impairment, or communication difficulties that prevent understanding of study procedures or pain assessment.\n\nPatients who refuse to participate in the study.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07445451', 'acronym': 'TURBT', 'briefTitle': 'Magnesium vs. Dexmedetomidine in TURBT Under Spinal Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of the Analgesic, Hemodynamic, and Respiratory Effects of Intravenous Magnesium Sulfate and Dexmedetomidine Infusions During Transurethral Bladder Tumor Resection Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'DrLutfiKirdarTRH-ANES-HY-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium Sulfate Infusion Group', 'description': 'Patients receive intravenous magnesium sulfate at 15 mg/kg/hour during TUR-M surgery under spinal anesthesia. Infusion solution is prepared aseptically by diluting the calculated dose in 50 mL of 0.9% NaCl. Postoperative analgesia is administered as rescue treatment based on VAS scores.', 'interventionNames': ['Drug: magnesium sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine Infusion Group', 'description': 'Patients receive intravenous dexmedetomidine at 0.5 µg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% NaCl and infused intravenously. Postoperative analgesia is given as rescue treatment according to VAS scores.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Saline Infusion)', 'description': 'Patients receive intravenous normal saline at 15 mL/kg/hour during TUR-M surgery under spinal anesthesia. Infusion is administered with the same protocol and devices as the experimental arms to maintain blinding. Postoperative analgesia is provided as rescue treatment based on VAS scores.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'magnesium sulfate', 'type': 'DRUG', 'description': 'Patients receive intravenous magnesium sulfate at 15 mg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.', 'armGroupLabels': ['Magnesium Sulfate Infusion Group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients receive intravenous dexmedetomidine at 0.5 µg/kg/hour during TUR-M surgery under spinal anesthesia. The calculated dose is diluted in 50 mL of 0.9% sodium chloride and infused intravenously throughout the surgery. Postoperative analgesia is provided as rescue treatment based on VAS scores.', 'armGroupLabels': ['Dexmedetomidine Infusion Group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Patients receive 15 mL/kg/hour of 0.9% sodium chloride without active pharmacological agents during TUR-M surgery under spinal anesthesia. Infusion is administered using the same protocol and devices as the experimental arms to maintain blinding. Postoperative analgesia is provided as rescue treatment based on VAS scores.', 'armGroupLabels': ['Control Group (Saline Infusion)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'SBÜ Kartal Dr. Lütfi Kırday City Hospital, İstanbul', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) will not be shared publicy due to local data privacy regulations and institutional policy. Aggregate results will be available in published form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician, Department of Anesthesiology and Reanimation', 'investigatorFullName': 'Halil Ibrahım Yuksel', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}