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Clinical Trial 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. The investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be assessed.


Clinical Trial 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 dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia.

The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.

Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.

Upon closure the study drug will be terminated. Patients will be followed up for 72 hours after surgery. Total opiate consumption and visual analogue scale ratings will be documented.

Intra and postoperative inotrope/pressor requirements will be recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01850017
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase Phase 4
Start date August 2012
Completion date May 2015