NCT01788202

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

February 5, 2013

Last Update Submit

September 6, 2016

Conditions

Emergent Surgery

Keywords

cocaine and general anesthesia

Outcome Measures

Primary Outcomes (1)

  • cardiac arrythmia

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

    intraoperatively

Secondary Outcomes (1)

  • hypotension

    intraoperatively

Other Outcomes (1)

  • Neurological deficit

    post operatively to 24 hours

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Failure to provide consent
  • females who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

Study Officials

  • J. Daniel Eloy, MD

    UMDNJ/NJMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 11, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)