Skip to content

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01788202
Enrollment
2
Registered
2013-02-11
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergent Surgery

Keywords

cocaine and general anesthesia

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.

Interventions

None listed

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cardiac arrythmiaintraoperativelyDid the patient require rescue medication for cardiac arrythmia such as tachycardia or ST segment elevation on EKG strip

Secondary

MeasureTime frameDescription
hypotensionintraoperativelydid subject require rescue for intraoperative hypotension

Other

MeasureTime frameDescription
Neurological deficitpost operatively to 24 hoursdoes the subject display post operatively neurological def

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026