Patients With Positive Urine Cocaine Metabolites Undergoing General Anesthesia

Terminated

• Conditions: Emergent Surgery

• Registration Number: NCT01788202
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac arrythmia	intraoperatively	Did the patient require rescue medication for cardiac arrythmia such as tachycardia or ST segment elevation on EKG strip

Secondary Outcome Measures

Name	Time	Method
hypotension	intraoperatively	did subject require rescue for intraoperative hypotension

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Newark, New Jersey, United States