Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-04 @ 1:39 PM
Study NCT ID:
NCT01788202
Status:
TERMINATED
Last Update Posted:
2016-09-08
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Positive Urine Cocaine Metabolites Undergoing General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'unable to enroll patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-07', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neurological deficit', 'timeFrame': 'post operatively to 24 hours', 'description': 'does the subject display post operatively neurological def'}], 'primaryOutcomes': [{'measure': 'cardiac arrythmia', 'timeFrame': 'intraoperatively', 'description': 'Did the patient require rescue medication for cardiac arrythmia such as tachycardia or ST segment elevation on EKG strip'}], 'secondaryOutcomes': [{'measure': 'hypotension', 'timeFrame': 'intraoperatively', 'description': 'did subject require rescue for intraoperative hypotension'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cocaine and general anesthesia'], 'conditions': ['Emergent Surgery']}, 'descriptionModule': {'briefSummary': 'When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. The study doctors would like to determine the effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery, the subjects will be observed in regards to mental status and any changes in heart rate and rhythm.', 'detailedDescription': 'The risks associated with administering general anesthesia to cocaine abusing patients with a positive urine cocaine metabolite is a major cause of cancellation of surgery in many trauma centers. Although many clinicians wait 24 to 48 hours after a positive urine drug screen before administering anesthesia, no standard or practical guidelines have yet to determine when it is safe to proceed with general anesthesia in this patient population. Due to the lack of guidelines for these cases, the rate of cancellation of procedures for these patients is high. The frequent cancelling of such cases causes a waste of resources, personnel, and time. The risks associated with cocaine use that cause most clinicians to cancel cases are mainly due to the cardiovascular effects of cocaine. Increases in blood pressure, heart rate, temperature, and the potential for myocardial infarction and fatal arrhythmias are what clinicians fear when administering general anesthesia to these patients. However, due to the urgency of some of the cases, it would be beneficial to both the patient and institutions to know when it is safe to proceed with the case and when it is not. When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. This observational study will evaluate the effects of general anesthesia on the cocaine abusing patient with cocaine positive urine drug screen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects requiring urgent surgeries for acute abdomen, orthopedic trauma and maxillary facial trauma cases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists rating of 1-111\n* Positive cocaine metabolite\n* urgent surgery for acute abdomen, orthopedic trauma, maxillary-facial trauma\n\nExclusion Criteria:\n\n* Failure to provide consent\n* females who are pregnant'}, 'identificationModule': {'nctId': 'NCT01788202', 'briefTitle': 'Patients With Positive Urine Cocaine Metabolites Undergoing General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'An Observational, Prospective Study in Patients With Positive Urine Cocaine Metabolites Undergoing Surgery for General Anesthesia', 'orgStudyIdInfo': {'id': '0120090260'}}, 'contactsLocationsModule': {'locations': [{'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'J. Daniel Eloy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMDNJ/NJMS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}