Cocaine Use and Outcomes of General Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Blood samples will be collected for analysis of cardiac troponin T (cTnT) pre- and postoperatively.

Official Title
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Cocaine Use and General Anesthesia: A Prospective Study of Cardiovascular and Anesthetic Effects

Conditions
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Anesthesia

Intervention / Treatment
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* Other: Urine cocaine negative
* Other: Urine cocaine positive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years old ASA physical status classification 1 to 3 Personal history of cocaine abuse Scheduled for a non-emergent operation that requires general anesthesia 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) Willing and able to consent in English or Spanish Exclusion Criteria: Age less than 18 or older than 70 Unable to give informed consent for participation in the study Patient refusal Monitored anesthesia care (MAC) or regional anesthesia planned Pregnant or lactating Emergent surgery Acute cocaine intoxication based on clinical symptomatology (hypertension, tachycardia, agitation, delirium, hyperthermia) History of cardiac disease including coronary artery disease (CAD) and cardiac dysrhythmia History of stroke History of seizure disorder ESRD Prison patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cocaine negative<br>Patients with preoperative urine cocaine negative results | Other: Urine cocaine negative<br>* Preoperative urine cocaine negative<br>|
| Cocaine positive<br>Patients with preoperative urine cocaine positive results | Other: Urine cocaine positive<br>* Preoperative urine cocaine positive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse intraoperative cardiovascular events | Proportion of total anesthesia duration that mean arterial pressure (MAP) <65 or >105 | Intraoperatively, from the time of anesthesia start until anesthesia end, generally 2-4 hours | 
| Adverse postoperative cardiovascular events | Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value | Postoperatively up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of volatile anesthetic used | Average minimum alveolar concentration sevoflurane | Intraoperatively, from the time of anesthesia start until anesthesia end, generally 2-4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Cocaine Use