Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05657756
Status:
UNKNOWN
Last Update Posted:
2022-12-20
First Post:
2022-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-11', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-12-11', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '100 patients were enrolled in our study, they are receiving muscle relaxants either Atracurium or rocuronium, and we recorded the muscle strength of the forearm in a postoperative location using an electronic hand dynamometer with a kilogram scale.', 'timeFrame': 'up to 6 months', 'description': 'record the neuromuscular recovery using a hand dynamometer with a kilogram scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Block Prolonged']}, 'descriptionModule': {'briefSummary': 'One of the common serious complications in the postoperative phase is Residual the neuromuscular blockade that confused the anesthesia medical team also patients may become uncomfortable, un ability to clear secretion, un-explanation of decreasing SPO2, increase respiratory effort and lead to an increase in the risk of respiratory complication. Most clinicians used clinical assessment to evaluate neuromuscular recovery such as a head lift for 5 seconds, Sustain leg lift, Tongue protrusion, teeth clenching, swallowing, Tidal volume 5 mL/kg, Handgrips Sustained for 5 seconds, and other clinical assessments in patients undergoing general anesthesia. A few studies have been discussing the utilization of hand dynamometers in the assessment of post-residual neuromuscular block. Our aim is to examine the neuromuscular recovery using a hand dynamometer after receiving Atracurium versus Rocuronium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patient between 18-60 years old with ASAII under general anesthesia\n\nExclusion Criteria:\n\n* all patient under 18 years old and over 60 years old\n* prior administration of suxamethonium\n* patient received magnesium, lithium, Quinidine, calcium channel blockers, local anesthesia'}, 'identificationModule': {'nctId': 'NCT05657756', 'briefTitle': 'Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Al Safwa University College'}, 'officialTitle': 'Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium', 'orgStudyIdInfo': {'id': 'hand dynamometer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Atracrium group', 'interventionNames': ['Device: Randomize clinical trial using hand dynamometer']}, {'type': 'OTHER', 'label': 'Rocoronium group', 'interventionNames': ['Device: Randomize clinical trial using hand dynamometer']}], 'interventions': [{'name': 'Randomize clinical trial using hand dynamometer', 'type': 'DEVICE', 'description': 'Our research article involves 100 patients aged over 18 years old with ASAI\\&II divided into two groups, 50 patients will receive atracurium (0.5 mg/kg) and 30 patients receive Rocuronium (0.6 mg/kg). All of our patients will be undergoing elective laparoscopic surgery for cholecystectomy; the patients will randomly select to receive standard anesthesia induction with propofol (2 mg/kg), fentanyl (1-2 mcg/kg), and isoflurane 1.2 Mac, except muscle relaxant. Neuromuscular will monitoring by Train-of-Four (TOF) during surgery.', 'armGroupLabels': ['Atracrium group', 'Rocoronium group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54001', 'city': 'Najaf', 'state': 'Adala', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'mohammed AZ sasaa, phd', 'role': 'CONTACT', 'email': 'm.abedalzahraa@alsafwa.edu.iq', 'phone': '009647718991533'}, {'name': 'ahmed AD sahib, phd', 'role': 'CONTACT', 'email': 'smralmmwry@gmail.com', 'phone': '009647815759208'}], 'facility': 'mohammed abdulzahra Sasaa', 'geoPoint': {'lat': 32.02594, 'lon': 44.34625}}], 'centralContacts': [{'name': 'Mohammed abdulzahra sasaa, phd', 'role': 'CONTACT', 'email': 'm.abedalzahraa@alsafwa.edu.iq', 'phone': '009647718991533', 'phoneExt': 'AZ'}, {'name': 'Ahmed AD sahib, phd', 'role': 'CONTACT', 'email': 'smralmmwry@gmail.com', 'phone': '009647815759208'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Safwa University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Mohammed AbdulZahra Sasaa', 'investigatorAffiliation': 'Al Safwa University College'}}}}