Cocaine Use and Outcomes of General Anesthesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02692534|
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : February 2, 2017
|Condition or disease||Intervention/treatment|
|Anesthesia||Other: Urine cocaine negative Other: Urine cocaine positive|
Patients with a history of cocaine abuse in the past year 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 300 cocaine positive and negative patients over a 2 year period.
Blood samples will be collected for analysis of inflammatory and cardiac biomarkers including C-reactive protein (CRP), IL-6, and cardiac troponin T (cTnT). After induction of general anesthesia and postoperative day 1, the inflammatory and cardiac biomarkers (troponin T) will be measured.
Subjects will be followed for adverse intraoperative cardiovascular events that are defined in two ways: 1) Proportion of total anesthesia duration that mean arterial pressure (MAP) <55 or >110 and 2) Proportion of total anesthesia duration that heart rate (HR) < 50 or >100. Adverse postoperative cardiovascular events will be defined in two ways: 1) Increase in the postoperative troponin value compared to the patient's baseline preoperative troponin value and 2) Postoperative myocardial infarction, stroke, or death.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Cocaine Use and General Anesthesia: A Prospective Study of Cardiovascular and Anesthetic Effects|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||December 2018|
Patients with preoperative urine cocaine negative results
Other: Urine cocaine negative
Preoperative urine cocaine negative
Patients with preoperative urine cocaine positive results
Other: Urine cocaine positive
Preoperative urine cocaine positive
- Adverse intraoperative cardiovascular events1 [ Time Frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end", approximately 2-4 hours ]Proportion of total anesthesia duration that mean arterial pressure (MAP) <55 or >110
- Adverse postoperative cardiovascular events [ Time Frame: The time of ''anesthesia stop'' until ''hospital discharge'' approximately 2-6 hours ]Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value
- The percentage of volatile anesthetics used [ Time Frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end", approximately 2-4 hours ]Different volatile anesthetics are measured by their percentage equivalent to 1 minimum alveolar concentration, and differs from 1.2% for isoflurane, up to 6% for desflurane.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692534
|Contact: Tiffany Moon, MD||(214) 590-8221||Tiffany.Moon@UTSouthwestern.edu|
|United States, Texas|
|Parkland Health & Hospital System||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Tiffany Moon, MD 214-590-8221 Tiffany.Moon@UTSouthwestern.edu|
|Principal Investigator:||Tiffany Moon, MD||University of Texas Southwestern Medical Center|