Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-31 @ 6:51 AM
Study NCT ID:
NCT00922467
Status:
TERMINATED
Last Update Posted:
2016-09-23
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Esmolol on a Closed-Loop Anesthesia System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C036604', 'term': 'esmolol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'lack of effectiveness', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'administered doses of propofol and of remifentanil during anesthesia', 'timeFrame': 'end of anesthesia'}], 'secondaryOutcomes': [{'measure': 'delay before recovery', 'timeFrame': 'at the end of anesthesia'}, {'measure': 'hemodynamic abnormalities requiring a treatment', 'timeFrame': 'end of anesthesia'}, {'measure': 'postoperative morphine requirement', 'timeFrame': 'Third post-anesthetic hour'}, {'measure': 'explicit memorisation', 'timeFrame': 'Second postoperative day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male patients scheduled for a general anesthesia\n\nExclusion Criteria:\n\n* age lower than 18 years\n* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,\n* any other history of anaphylactic reaction,\n* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,\n* hypersensibility to esmolol or to an excipient,\n* history of central nervous system disease,\n* patients receiving a psychotropic treatment or an agonist-antagonist opiate,\n* hypovolemic patients,\n* patients receiving a cardio-vascular treatment,\n* patients with a pacemaker,\n* expected bleeding more than 20% of the blood volume,\n* simultaneous general and loco-regional anesthesia,\n* patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,\n* patients with a heart rate less than 50/min and/or an arterial hypotension,\n* neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.'}, 'identificationModule': {'nctId': 'NCT00922467', 'briefTitle': 'Influence of Esmolol on a Closed-Loop Anesthesia System', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol', 'orgStudyIdInfo': {'id': '2008/47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo', 'interventionNames': ['Drug: NaCl 9/00']}, {'type': 'EXPERIMENTAL', 'label': 'Esmolol', 'description': 'patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol', 'interventionNames': ['Drug: Esmolol']}], 'interventions': [{'name': 'NaCl 9/00', 'type': 'DRUG', 'description': 'Same volume as in the esmolol group', 'armGroupLabels': ['Placebo']}, {'name': 'Esmolol', 'type': 'DRUG', 'description': '1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period', 'armGroupLabels': ['Esmolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}