Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-17 @ 2:53 PM
Study NCT ID:
NCT01477905
Status:
COMPLETED
Last Update Posted:
2011-11-23
First Post:
2011-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil
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': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-22', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-22', 'lastUpdatePostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delivered infusates of remifentanil', 'timeFrame': 'base line from 30 min of TCI was maintained', 'description': 'For targetting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) or 20 μg/ml (Remi20) of remifentanil, and with or without PRIMING, TCI data files, including predicted plasma (Cp-proper), and effect-site (Ceff-proper) concentrations were saved'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['priming', 'remifentanil', 'target-controlled infusion'], 'conditions': ['Intravenous Drug Usage']}, 'referencesModule': {'references': [{'pmid': '9640119', 'type': 'RESULT', 'citation': "Swinhoe CF, Peacock JE, Glen JB, Reilly CS. Evaluation of the predictive performance of a 'Diprifusor' TCI system. Anaesthesia. 1998 Apr;53 Suppl 1:61-7. doi: 10.1111/j.1365-2044.1998.53s104.x."}]}, 'descriptionModule': {'briefSummary': 'The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.', 'detailedDescription': 'Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* electric medical records of the patients who had undergone general anaesthesia\n\nExclusion Criteria:\n\n* body weight exceeding 20% of ideal body weight'}, 'identificationModule': {'nctId': 'NCT01477905', 'briefTitle': 'Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe', 'orgStudyIdInfo': {'id': 'AJIRB-DEV-DEO-11-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remi50 no prime', 'description': 'For using experimental target control infusion device (TCIs), targeting an effect-site concentration (Ceff) of 4.0 ng/ml, were randomly performed using 50 μg/ml (Remi50) of remifentanil, and without PRIMING,', 'interventionNames': ['Device: Remi50 with prime']}, {'type': 'EXPERIMENTAL', 'label': 'Remi20 no prmie', 'description': 'For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and without PRIMING', 'interventionNames': ['Device: Remi20 with prime']}], 'interventions': [{'name': 'Remi50 with prime', 'type': 'DEVICE', 'otherNames': ['remi50 prime'], 'description': 'for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING', 'armGroupLabels': ['Remi50 no prime']}, {'name': 'Remi20 with prime', 'type': 'DEVICE', 'otherNames': ['remi20 prime'], 'description': 'For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING', 'armGroupLabels': ['Remi20 no prmie']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University School of Medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jong Yeop Kim, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}