Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 8:50 PM
Study NCT ID:
NCT04921735
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2021-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C101584', 'term': 'cisatracurium'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2021-06-05', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset time', 'timeFrame': 'within 10 minutes after administration', 'description': 'the time from the start of the injection of cisatracurium to train-of-four (TOF) count of 0 monitored by acceleromyography'}], 'secondaryOutcomes': [{'measure': 'Duration of action', 'timeFrame': 'within 120 minutes after administration of cisatracurium', 'description': 'Duration of action is defined as time from start of cisatracurium injection to reappearance of TOF ratio \\> 0.9.'}, {'measure': 'intubation conditions', 'timeFrame': 'within 10 minutes after administration of cistracurium', 'description': 'intubation conditions are rated according to intubating difficulty score IDS when TOF-ratio is 0.'}, {'measure': 'intubation conditions', 'timeFrame': 'within 10 minutes after administration of cisatracurium', 'description': 'intubation conditions are rated according to Fuchs-Buder score when TOF-ratio is 0.'}, {'measure': 'Laryngeal morbidity', 'timeFrame': '24 hours after surgery', 'description': 'After 24 hours patients are asked about hoarseness and sore throat. Patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale from 0 to 10.'}, {'measure': 'Amount of ephedrine or metaoxedrine administered', 'timeFrame': 'within 10 minutes after administration of cisatracurium', 'description': 'If ephedrine or metaoxedrine is administered after induction of anaesthesia and until the patient is ready for properly positioning for surgery, it will be noted in the CRF, as well as the amount administered. Changes in blood pressure or heart rate are treated according to local guidelines.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Onset Time of Cisatracurium', 'Duration of Action of Cisatracurium', 'Intubation Conditions']}, 'referencesModule': {'references': [{'pmid': '36344924', 'type': 'DERIVED', 'citation': 'Vested M, Kristensen CM, Pape P, Vang M, Hartoft M, Hjelmdal C, Rasmussen LS. Comparison of onset time, duration of action, and intubating conditions after cisatracurium 0.15 mg/kg in young and elderly patients. BMC Anesthesiol. 2022 Nov 7;22(1):339. doi: 10.1186/s12871-022-01881-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.', 'detailedDescription': 'The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (\\>80 years) has a longer onset time and duration of action compared to younger patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥ 80 or ≥18 - ≤40 years of age\n2. Informed consent\n3. Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia \\> 1 hour) with intubation and use of cisatracurium\n4. American Society of Anaesthesiologists (ASA) physical status classification I to III\n5. Can read and understand Danish\n\nExclusion Criteria:\n\n1. Known allergy to cisatracurium\n2. Neuromuscular disease\n3. Indication for rapid sequence induction\n4. Surgery in the prone position'}, 'identificationModule': {'nctId': 'NCT04921735', 'briefTitle': 'An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'An Observational Study of Cisatracurium 0.15 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (≥ 80 Years) Patients.', 'orgStudyIdInfo': {'id': 'Cisatracurium 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly', 'description': 'patients aged 80 years or older', 'interventionNames': ['Drug: Cisatracurium']}, {'label': 'young', 'description': 'patients aged 18-40 years', 'interventionNames': ['Drug: Cisatracurium']}], 'interventions': [{'name': 'Cisatracurium', 'type': 'DRUG', 'description': '0.15 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower', 'armGroupLabels': ['Elderly', 'young']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matias Vested', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Matias Vested', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}