Skip to main content
OpenTrials
Completed

NCT Number: NCT02692534

Cocaine Use and Outcomes of General Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine cocaine negative

Other

Preoperative urine cocaine negative

Urine cocaine positive

Other

Preoperative urine cocaine positive

Primary outcomes

  1. Adverse intraoperative cardiovascular events

    Time frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours

    Proportion of total anesthesia duration that mean arterial pressure (MAP) <65 or >105

  2. Adverse postoperative cardiovascular events

    Time frame: Postoperatively up to 24 hours

    Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value

Secondary outcomes

  1. The percentage of volatile anesthetic used

    Time frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours

    Average minimum alveolar concentration sevoflurane

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.