Cocaine Use and Outcomes of General Anesthesia

July 8, 2019 updated by: Tiffany B Moon, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Parkland Health & Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ASA physical status 1-3 subjects with cocaine use disorder who are scheduled to undergo surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cocaine negative
Patients with preoperative urine cocaine negative results
Other: Urine cocaine negative
Preoperative urine cocaine negative
Cocaine positive
Patients with preoperative urine cocaine positive results
Other: Urine cocaine positive
Preoperative urine cocaine positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours
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
Postoperatively up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 062015-066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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