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Trial record 3 of 149 for:    cocaine OR heroin OR ecstasy | Recruiting, Not yet recruiting Studies

Cocaine Use and Outcomes of General Anesthesia

This study is currently recruiting participants.
Verified January 2017 by Tiffany B Moon, University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02692534
First Posted: February 26, 2016
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention
Anesthesia Other: Urine cocaine negative Other: Urine cocaine positive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cocaine Use and General Anesthesia: A Prospective Study of Cardiovascular and Anesthetic Effects

Resource links provided by NLM:


Further study details as provided by Tiffany B Moon, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Adverse intraoperative cardiovascular events1 [ Time Frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end", approximately 2-4 hours ]
    Proportion of total anesthesia duration that mean arterial pressure (MAP) <55 or >110

  • Adverse postoperative cardiovascular events [ Time Frame: The time of ''anesthesia stop'' until ''hospital discharge'' approximately 2-6 hours ]
    Increase in the postoperative troponin value compared to the patient¹s baseline preoperative troponin value


Secondary Outcome Measures:
  • The percentage of volatile anesthetics used [ Time Frame: Intraoperatively, from the time of "anesthesia start" until "anesthesia end", approximately 2-4 hours ]
    Different volatile anesthetics are measured by their percentage equivalent to 1 minimum alveolar concentration, and differs from 1.2% for isoflurane, up to 6% for desflurane.


Estimated Enrollment: 300
Study Start Date: April 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Patients with a history of cocaine abuse in the past year 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 300 cocaine positive and negative patients over a 2 year period.

Blood samples will be collected for analysis of inflammatory and cardiac biomarkers including C-reactive protein (CRP), IL-6, and cardiac troponin T (cTnT). After induction of general anesthesia and postoperative day 1, the inflammatory and cardiac biomarkers (troponin T) will be measured.

Subjects will be followed for adverse intraoperative cardiovascular events that are defined in two ways: 1) Proportion of total anesthesia duration that mean arterial pressure (MAP) <55 or >110 and 2) Proportion of total anesthesia duration that heart rate (HR) < 50 or >100. Adverse postoperative cardiovascular events will be defined in two ways: 1) Increase in the postoperative troponin value compared to the patient's baseline preoperative troponin value and 2) Postoperative myocardial infarction, stroke, or death.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ASA physical status 1-3 subjects with cocaine use disorder who are scheduled to undergo surgery.
Criteria

Inclusion Criteria:

  • 18-70 years old
  • ASA physical status classification 1 to 3
  • Personal history of cocaine abuse in the last year
  • 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 with use of appropriate language translator

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 nursing women
  • Emergent surgery (designated with an E on the end of the ASA status)
  • Patient on other illicit drugs except marijuana (e.g., amphetamine)
  • 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
  • On dialysis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692534


Contacts
Contact: Tiffany Moon, MD (214) 590-8221 Tiffany.Moon@UTSouthwestern.edu

Locations
United States, Texas
Parkland Health & Hospital System Recruiting
Dallas, Texas, United States, 75390
Contact: Tiffany Moon, MD    214-590-8221    Tiffany.Moon@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: Tiffany B Moon, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02692534     History of Changes
Other Study ID Numbers: STU 062015-066
First Submitted: January 21, 2016
First Posted: February 26, 2016
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tiffany B Moon, University of Texas Southwestern Medical Center:
Anesthesia
Cocaine Use

Additional relevant MeSH terms:
Cocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents