Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06966518
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-05-04', 'studyFirstSubmitQcDate': '2025-05-04', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) \\> 3, to be repeated after 30 min if pain persists until the NRS \\< 4.'}], 'secondaryOutcomes': [{'measure': 'Time to the 1st rescue analgesia.', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).'}, {'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 6, 8, 12, 18, and 24 h postoperatively.'}, {'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Mean arterial pressure will be recorded preoperatively and every 15 minutes till the end of surgery.'}, {'measure': 'Degree of patient satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)'}, {'measure': 'Incidence of adverse events.', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative', 'Ketamine', 'Magnesium Sulfate', 'Postoperative Analgesia', 'Rhinoplasty']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.', 'detailedDescription': 'Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications.\n\nKetamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems.\n\nMagnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids.\n\nKetamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status I - II.\n* Scheduled for rhinoplasty under general anesthesia.\n\nExclusion Criteria:\n\n* Receiving analgesic or any medications since 48 hours before the surgery.\n* Drug addiction.\n* Cardiovascular disease.\n* Respiratory disease, renal, liver, metabolic and neurological disease.\n* Pregnancy or breast feeding.\n* Asthma.'}, 'identificationModule': {'nctId': 'NCT06966518', 'briefTitle': 'Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR1199/4/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KM Group', 'description': 'Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.', 'interventionNames': ['Drug: Ketamine and Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive saline 0.9% as a control group.', 'interventionNames': ['Drug: Saline 0.9%']}], 'interventions': [{'name': 'Ketamine and Magnesium Sulfate', 'type': 'DRUG', 'description': 'Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr.', 'armGroupLabels': ['KM Group']}, {'name': 'Saline 0.9%', 'type': 'DRUG', 'description': 'Patients will receive saline 0.9% as a control group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sarah A Afifi, MD', 'role': 'CONTACT', 'email': 'Sarah606060@gmail.com', 'phone': '0501035864'}, {'name': 'Maram I Elmazny, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sondos Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sarah A Afifi, MD', 'role': 'CONTACT', 'email': 'Sarah606060@gmail.com', 'phone': '0501035864'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Intensive care, and pain management, Faculty of Medicine, Ain Shams University, Cairo, Egypt.', 'investigatorFullName': 'Sarah Ahmed', 'investigatorAffiliation': 'Ain Shams University'}}}}