Cocaine Use and Outcomes of General Anesthesia

Completed

• Conditions: Anesthesia
• Interventions: Other: Urine cocaine negative; Other: Urine cocaine positive

• Registration Number: NCT02692534
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-04
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cocaine negative	Urine cocaine negative	Patients with preoperative urine cocaine negative results
Cocaine positive	Urine cocaine positive	Patients with preoperative urine cocaine positive results

Primary Outcome Measures

Name	Time	Method
Adverse intraoperative cardiovascular events	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
Adverse postoperative cardiovascular events	Postoperatively up to 24 hours	Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value

Secondary Outcome Measures

Name	Time	Method
The percentage of volatile anesthetic used	Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours	Average minimum alveolar concentration sevoflurane

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States