Cocaine Use and Outcomes of General Anesthesia

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Anesthesia

Treatments

Other: Urine cocaine negative
Other: Urine cocaine positive

Study type

Observational

Funder types

Other

Identifiers

NCT02692534
STU 062015-066

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Cocaine negative
Description:
Patients with preoperative urine cocaine negative results
Treatment:
Other: Urine cocaine negative
Cocaine positive
Description:
Patients with preoperative urine cocaine positive results
Treatment:
Other: Urine cocaine positive

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems