Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT02669368
Status:
UNKNOWN
Last Update Posted:
2016-02-01
First Post:
2016-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulfate Effects on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077123', 'term': 'Rocuronium'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2016-01-25', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time of onset the action of Rocuronium', 'timeFrame': 'Time from injection of Rocuronium till T1 suppression more than 95% up to 10 minutes.', 'description': 'by using the TOF watch nerve stimulator'}, {'measure': 'The time at which Maximal suppression', 'timeFrame': 'Time from the injection of Rocuronium to T1 maximal suppression time (TOF=0) up to an hour.', 'description': 'by using the TOF watch nerve stimulator'}, {'measure': 'Reversal of Rocuronium', 'timeFrame': 'Time from injection of Rocuronium till reversal of T1 (TOF=25%) around an hour after induction of anesthesia', 'description': 'by using the TOF watch nerve stimulator'}], 'secondaryOutcomes': [{'measure': 'Intubation condition', 'timeFrame': 'Within 10 minutes after induction of anesthesia', 'description': 'to score intubation condition on the basis of 6 items: Jaw relaxation, laryngoscopy, vocal cord position, moving of limbs, coughing \\& change in heart rate.'}, {'measure': 'Surgical condition', 'timeFrame': 'During surgery', 'description': 'to score a surgical condition according to 7 point likert scale'}]}, 'conditionsModule': {'conditions': ['Muscle Relaxation']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition in patients undergoing laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status 1 or 2.\n* BMI of 25-34.9 kg/m2.\n* Patients scheduled for laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n* Severe respiratory or cardiac disease.\n* Hepatic or renal function impairment.\n* Neuromuscular disease.\n* Patients on medications affecting neuromuscular function.\n* Patients with known allergy to the drugs.'}, 'identificationModule': {'nctId': 'NCT02669368', 'briefTitle': 'Magnesium Sulfate Effects on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '01MgRo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose Rocuronium', 'description': 'Pretreatment of saline 100ml then giving Rocuronium 0.6 mg/kg at induction of anesthesia.', 'interventionNames': ['Drug: Saline', 'Drug: Standard dose Rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose Rocuronium', 'description': 'Pretreatment of saline 100ml then giving Rocuronium 0.45 mg/kg at induction of anesthesia.', 'interventionNames': ['Drug: Saline', 'Drug: Low dose Rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose Rocuronium + Magnesium Sulfate', 'description': 'Pretreatment of Magnesium sulfate 30 mg/kg then giving Rocuronium 0.45 mg/kg at induction of anesthesia.', 'interventionNames': ['Drug: Magnesium Sulfate', 'Drug: Low dose Rocuronium']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Patients in each group receive Magnesium sulfate 30 mg/kg in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia', 'armGroupLabels': ['Low dose Rocuronium + Magnesium Sulfate']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia', 'armGroupLabels': ['Low dose Rocuronium', 'Standard dose Rocuronium']}, {'name': 'Standard dose Rocuronium', 'type': 'DRUG', 'description': '0.6 mg/kg of Rocuronium given with induction of anesthesia', 'armGroupLabels': ['Standard dose Rocuronium']}, {'name': 'Low dose Rocuronium', 'type': 'DRUG', 'description': '0.45 mg/kg of Rocuronium given with induction of anesthesia', 'armGroupLabels': ['Low dose Rocuronium', 'Low dose Rocuronium + Magnesium Sulfate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71121', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut University Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Nawal Abdelaziz Gadelrab, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Ola Mahmoud Wahba, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University Hospitals'}, {'name': 'Ahmed Hamada Hamed Amin, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ahmed Hamada Hamed', 'investigatorAffiliation': 'Assiut University'}}}}