Collapse of Lumbar Vertebrae, Collapse of Thoracic Vertebra
Conditions
Keywords
Opiate consumption, Visual Analogue Scale
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. 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.
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 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.
Interventions
DRUGDexmedetomidine
In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-80 years of age * Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate consumption | 72 hours post surgery | We will measure total opiate consumption 72 hours post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog Scale | 72 hours | We will measure pain scores on the Visual analogue scale after surgery |
Countries
United States
Outcome results
None listed