Status:

COMPLETED

Study of Dexmedetomidine in Spine Surgery

Lead Sponsor:

University of Virginia

Conditions:

Collapse of Thoracic Vertebra

Collapse of Lumbar Vertebrae

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. ...

Detailed Description

Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized to a placebo or dexmedet...

Eligibility Criteria

Inclusion

  • Age 18-80 years of age
  • Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring

Exclusion

  • Emergency spine surgery
  • Age \< 18 years
  • Pregnant patients
  • Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a previous EKG.
  • Any individual with stage 4 or greater chronic kidney disease (eGFR\< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure
  • Any individuals on preoperative methadone therapy
  • Preoperative dexmedetomidine use
  • Preoperative systolic hypertension defined by a systolic blood pressure greater than 150 mmHg in the surgical admission suite
  • Enrolled in another study within 30 days

Key Trial Info

Start Date :

August 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT01850017

Start Date

August 1 2012

End Date

May 1 2015

Last Update

May 5 2017

Active Locations (1)

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1

University of Virginia

Charlottesville, Virginia, United States, 22908