Cocaine Use and Outcomes of General Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692534
• Other study ID #: STU 062015-066
• Status: Completed
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Urine cocaine negative
Preoperative urine cocaine negative
• Urine cocaine positive
Preoperative urine cocaine positive

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse intraoperative cardiovascular events	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
Primary	Adverse postoperative cardiovascular events	Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value	Postoperatively up to 24 hours
Secondary	The percentage of volatile anesthetic used	Average minimum alveolar concentration sevoflurane	Intraoperatively, from the time of "anesthesia start" until "anesthesia end," generally 2-4 hours