Study of Dexmedetomidine in Spine Surgery

University of Virginia142 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

142

Conditions

Collapse of Thoracic Vertebra Collapse of Lumbar Vertebrae

Interventions

DexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Opiate consumption

We will measure total opiate consumption 72 hours post surgery

Time frame: 72 hours post surgery

Secondary Outcomes

Pain Scores on the Visual Analog Scale

We will measure pain scores on the Visual analogue scale after surgery

Time frame: 72 hours

Data from ClinicalTrials.gov

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