Clinical trial NCT02692534: Cocaine Use and Outcomes of General Anesthesia
Official title: Cocaine Use and General Anesthesia: A Prospective Study of Cardiovascular and Anesthetic Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Anesthesia
Cocaine Use
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA physical status 1-3 subjects with cocaine use disorder who are scheduled to undergo surgery.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse intraoperative cardiovascular events
timeFrame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours
measure: Adverse postoperative cardiovascular events
timeFrame: Postoperatively up to 24 hours
Secondary outcomes:
measure: The percentage of volatile anesthetic used
timeFrame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Tiffany Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.