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Cocaine Use and Outcomes of General Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02692534
Enrollment
300
Registered
2016-02-26
Start date
2016-04-30
Completion date
2018-02-28
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Cocaine Use

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.

Interventions

OTHERUrine cocaine negative

Preoperative urine cocaine negative

OTHERUrine cocaine positive

Preoperative urine cocaine positive

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse intraoperative cardiovascular eventsIntraoperatively, from the time of anesthesia start until anesthesia end, generally 2-4 hoursProportion of total anesthesia duration that mean arterial pressure (MAP) \<65 or \>105
Adverse postoperative cardiovascular eventsPostoperatively up to 24 hoursIncrease in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value

Secondary

MeasureTime frameDescription
The percentage of volatile anesthetic usedIntraoperatively, from the time of anesthesia start until anesthesia end, generally 2-4 hoursAverage minimum alveolar concentration sevoflurane

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026