Patients With Positive Urine Cocaine Metabolites Undergoing General Anesthesia

An Observational, Prospective Study in Patients With Positive Urine Cocaine Metabolites Undergoing Surgery for General Anesthesia

When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. The study doctors would like to determine the effect of cocaine on blood pressure, heart rate and rhythm during surgery. After surgery, the subjects will be observed in regards to mental status and any changes in heart rate and rhythm.

Study Overview

• Status: Terminated
• Conditions: Emergent Surgery

Detailed Description

The risks associated with administering general anesthesia to cocaine abusing patients with a positive urine cocaine metabolite is a major cause of cancellation of surgery in many trauma centers. Although many clinicians wait 24 to 48 hours after a positive urine drug screen before administering anesthesia, no standard or practical guidelines have yet to determine when it is safe to proceed with general anesthesia in this patient population. Due to the lack of guidelines for these cases, the rate of cancellation of procedures for these patients is high. The frequent cancelling of such cases causes a waste of resources, personnel, and time. The risks associated with cocaine use that cause most clinicians to cancel cases are mainly due to the cardiovascular effects of cocaine. Increases in blood pressure, heart rate, temperature, and the potential for myocardial infarction and fatal arrhythmias are what clinicians fear when administering general anesthesia to these patients. However, due to the urgency of some of the cases, it would be beneficial to both the patient and institutions to know when it is safe to proceed with the case and when it is not. When it is safe to administer general anesthesia to the patient with cocaine positive urine drug screen has never been clearly determined. This observational study will evaluate the effects of general anesthesia on the cocaine abusing patient with cocaine positive urine drug screen.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects requiring urgent surgeries for acute abdomen, orthopedic trauma and maxillary facial trauma cases.

Description

Inclusion Criteria:

• American Society of Anesthesiologists rating of 1-111
• Positive cocaine metabolite
• urgent surgery for acute abdomen, orthopedic trauma, maxillary-facial trauma

Exclusion Criteria:

• Failure to provide consent
• females who are pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac arrythmia	Did the patient require rescue medication for cardiac arrythmia such as tachycardia or ST segment elevation on EKG strip	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	did subject require rescue for intraoperative hypotension	intraoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological deficit	does the subject display post operatively neurological def	post operatively to 24 hours

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: J. Daniel Eloy, MD, UMDNJ/NJMS

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: cocaine and general anesthesia
• Other Study ID Numbers: 0120090260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO