Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT02692534
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cocaine Use and Outcomes of General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse intraoperative cardiovascular events', 'timeFrame': 'Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours', 'description': 'Proportion of total anesthesia duration that mean arterial pressure (MAP) \\<65 or \\>105'}, {'measure': 'Adverse postoperative cardiovascular events', 'timeFrame': 'Postoperatively up to 24 hours', 'description': 'Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value'}], 'secondaryOutcomes': [{'measure': 'The percentage of volatile anesthetic used', 'timeFrame': 'Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours', 'description': 'Average minimum alveolar concentration sevoflurane'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Cocaine Use'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '32304462', 'type': 'DERIVED', 'citation': 'Moon TS, Pak TJ, Kim A, Gonzales MX, Volnov Y, Wright E, Vu KQ, Lu RD, Sharifi A, Minhajuddin A, Chen JL, Fox PE, Gasanova I, Fox AA, Stewart J, Ogunnaike B. A Positive Cocaine Urine Toxicology Test and the Effect on Intraoperative Hemodynamics Under General Anesthesia. Anesth Analg. 2021 Feb 1;132(2):308-316. doi: 10.1213/ANE.0000000000004808.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective study, investigators plan to evaluate the outcome of general anesthesia in the context of patients with a positive cocaine urine test. Patients with a positive urine cocaine test who do not appear acutely toxic and have normal vital signs may not have an increased rate of perioperative complications during elective surgery compared to similar patients with negative urine cocaine screening tests. Patients who are chronic cocaine users may have a higher anesthetic requirement.', 'detailedDescription': 'Patients with a history of cocaine abuse who are scheduled to undergo surgery at Parkland Hospital will be asked to provide a urine sample for a screening toxicology test on the day of surgery. Patients will also be asked to fill out a questionnaire with questions pertaining to their drug use history. The remaining aspects of perioperative care, including the general anesthetic technique, will be standardized for all patients and will not differ from the standard of care. The anesthesia faculty, resident, or CRNA will identify patients and obtain consent and ask the patient to fill out the questionnaire. This prospective study is intended to enroll about 300 cocaine positive and negative patients over a 2 year period.\n\nBlood samples will be collected for analysis of cardiac troponin T (cTnT) pre- and postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ASA physical status 1-3 subjects with cocaine use disorder who are scheduled to undergo surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years old\n* ASA physical status classification 1 to 3\n* Personal history of cocaine abuse\n* Scheduled for a non-emergent operation that requires general anesthesia\n* Vital signs within generally accepted ranges for normal \\[HR 60-100, RR 12-20, SpO2 \\> 96% on room air, BP 90-140/60-90 unless a diagnosis of hypertension is present, T 36-38 degrees)\n* Willing and able to consent in English or Spanish\n\nExclusion Criteria:\n\n* Age less than 18 or older than 70\n* Unable to give informed consent for participation in the study\n* Patient refusal\n* Monitored anesthesia care (MAC) or regional anesthesia planned\n* Pregnant or lactating\n* Emergent surgery\n* Acute cocaine intoxication based on clinical symptomatology (hypertension, tachycardia, agitation, delirium, hyperthermia)\n* History of cardiac disease including coronary artery disease (CAD) and cardiac dysrhythmia\n* History of stroke\n* History of seizure disorder\n* ESRD\n* Prison patient'}, 'identificationModule': {'nctId': 'NCT02692534', 'briefTitle': 'Cocaine Use and Outcomes of General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Cocaine Use and General Anesthesia: A Prospective Study of Cardiovascular and Anesthetic Effects', 'orgStudyIdInfo': {'id': 'STU 062015-066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cocaine negative', 'description': 'Patients with preoperative urine cocaine negative results', 'interventionNames': ['Other: Urine cocaine negative']}, {'label': 'Cocaine positive', 'description': 'Patients with preoperative urine cocaine positive results', 'interventionNames': ['Other: Urine cocaine positive']}], 'interventions': [{'name': 'Urine cocaine negative', 'type': 'OTHER', 'description': 'Preoperative urine cocaine negative', 'armGroupLabels': ['Cocaine negative']}, {'name': 'Urine cocaine positive', 'type': 'OTHER', 'description': 'Preoperative urine cocaine positive', 'armGroupLabels': ['Cocaine positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health & Hospital System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Tiffany Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tiffany B Moon', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}