Clinical trial NCT01788202: Patients With Positive Urine Cocaine Metabolites Undergoing General Anesthesia
Official title: An Observational, Prospective Study in Patients With Positive Urine Cocaine Metabolites Undergoing Surgery for General Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Emergent Surgery
Keywords: cocaine and general anesthesia
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects requiring urgent surgeries for acute abdomen, orthopedic trauma and maxillary facial trauma cases.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiac arrythmia
timeFrame: intraoperatively
Secondary outcomes:
measure: hypotension
timeFrame: intraoperatively
Other outcomes:
measure: Neurological deficit
timeFrame: post operatively to 24 hours
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: UMDNJ/NJMS
name: J. Daniel Eloy, MD
role: PRINCIPAL_INVESTIGATOR
References: