Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-03 @ 12:39 AM
Study NCT ID:
NCT06477133
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '30 minutes after awakening from anesthesia', 'description': 'Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '60 minutes after awakening from anesthesia', 'description': 'Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.'}, {'measure': 'Pain score', 'timeFrame': '120 minutes after awakening from anesthesia', 'description': 'Patients will be asked to assess their pain based on a 10-point scale, where 0=no pain and 10=worst imaginable pain.'}, {'measure': 'Number of participants who experienced nausea or vomiting', 'timeFrame': 'Up to 120 minutes after awakening from anesthesia'}, {'measure': 'Number of participants who experienced postoperative shivering', 'timeFrame': 'Up to 120 minutes after awakening from anesthesia'}, {'measure': 'Number of participants who received analgesics in the post anesthesia care unit (PACU)', 'timeFrame': 'Through PACU stay, on average 2 hours'}, {'measure': 'Time to administration of analgesics', 'timeFrame': 'From awakening from anesthesia to administration of analgesic, up to 120 minutes postoperative'}, {'measure': 'Dose of opioid analgesia given', 'timeFrame': 'Through PACU stay, on average 2 hours', 'description': 'Dose of opioid analgesia given will be measured in milligram morphine equivalents'}, {'measure': 'Number of patients who were admitted to the hospital', 'timeFrame': 'From PACU admission to discharge, up to 120 minutes postoperative'}, {'measure': 'Number of patients who were discharged home', 'timeFrame': 'From PACU admission to discharge, up to 120 minutes postoperative'}, {'measure': 'Train-of-four (TOF) ratio', 'timeFrame': 'TOF ratios will be measured for the duration of the operation, approximately 3 hours', 'description': 'Train- of-four ratio (TOF) is the ratio of the fourth muscle response to the first one.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate surgery', 'analgesia'], 'conditions': ['Prostatectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to determine if receiving magnesium sulfate as an adjunctive analgesic for prostate surgery is effective in reducing pain. Subjects will be randomized to receive magnesium or not receive it, as part of a standardized general anesthetic for prostate surgery. The primary objective is to demonstrate improved pain scores in patients receiving magnesium sulfate as an adjunctive analgesic during surgery. Secondary objectives include demonstrating reduced requirements for other opioids, reduced postoperative shivering, improved discharge home and adequate neuromuscular blockade reversal, measured by quantitative train of four monitoring.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 and older.\n2. Undergoing a robotic prostatectomy under general anesthesia.\n3. Is willing and able to provide consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years\n2. Patients with end-stage renal disease\n3. Known allergy to magnesium sulfate preparations\n4. Any patient that the investigators feel cannot comply with all study related procedures'}, 'identificationModule': {'nctId': 'NCT06477133', 'briefTitle': 'Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized, Controlled Trial of Magnesium Sulfate as an Adjunctive Analgesic in Prostate Surgery', 'orgStudyIdInfo': {'id': '24-00463'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium', 'description': 'Patients in the first group will receive 2 grams magnesium sulfate at the end of surgery as a bolus over approximately 10 minutes intravenously.', 'interventionNames': ['Drug: Magnesium sulfate']}, {'type': 'NO_INTERVENTION', 'label': 'No magnesium', 'description': 'Patients in the second group will receive no magnesium.'}], 'interventions': [{'name': 'Magnesium sulfate', 'type': 'DRUG', 'description': 'Pre-mixed solution of 2 grams of magnesium sulfate dissolved in 20 mL sterile water', 'armGroupLabels': ['Magnesium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Mark Nunnally, MD', 'role': 'CONTACT', 'email': 'nunnally@nyulangone.org', 'phone': '212-263-2087'}], 'overallOfficials': [{'name': 'Mark E. Nunnally, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research, provided the investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University\'s data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided). The protocol, Statistical Analysis Plan, and Informed Consent Form will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University\'s data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}