Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Condition: Spinal Fusion Acquired; Spinal Stenosis; Lesions of Lumbosacral Intervertebral Disc; Spinal Diseases
MeSH terms: Spinal Stenosis; Spinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Major lumbar spine surgery causes inflammation, soreness and swelling that can delay
      discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory
      effects. This study will evaluate whether DEX can help get patients out of the hospital
      faster after major spine surgery by reducing the inflammation associated with the procedure
      itself. A separate part of the study will evaluate the blood levels of some specific
      indicators of inflammation called cytokines. Measuring cytokines before and after surgery
      will aid in determining if DEX has altered the inflammatory response.
    

Detailed description: 
      Inflammation is a two-edged sword, one edge essential for healing, the other potentially
      delaying recovery. There is evidence that modest attenuation of the initial course of the
      inflammatory response (IR) - essentially "banking the fire" of the early IR - may be of
      benefit in shortening overall hospital course. Several medications have been
      evaluated/utilized intra- and perioperatively to modulate different components of IR,
      including local anesthetics, steroids and non-steroidal drugs. Additionally, the pro-and
      anti-inflammatory properties of various alpha- and beta-adrenergic agonists and antagonists
      have been characterized. Of this last category, dexmedetomidine (DEX), a highly specific
      ligand for all the subtypes of the alpha-2 receptor throughout the body, has substantial
      potency for sedation, analgesia and a reduction in the stress response in a wide variety of
      surgical environments as well as contributing to cardiovascular stability during Coronary
      Artery Bypass Graft (CABG) and open craniotomy. Additionally, DEX has been shown to have
      quite powerful anti-inflammatory activity in a murine endotoxin model. DEX's
      anti-inflammatory activity is likely expressed at G protein-coupled receptors (GPCRs) -
      either conformationally similar to, or the actual "native" alpha-2 receptor - on
      polymorphonuclear leukocytes, tissue macrophages, mast cells and other immune system cells.
      Through these receptors, DEX may attenuate the early phase of IR by limiting immune signaling
      or release of inflammatory cytokines, potentially favorably limiting the body's IR to injury.

      In this present study, our primary assumption is that an ordinarily exuberant IR would be
      invoked by major spine fusion surgery. Continuous administration of intravenous DEX during
      and immediately after surgery might sufficiently modulate the IR to shorten hospital stay.
      Therefore, in a prospective, randomized, placebo-controlled, double blinded fashion, we plan
      to evaluate the potential for a perioperative infusion of DEX to reduce
      "time-to-fitness-for-discharge" (generally easier to mark and a more accurate surrogate of
      time-to-discharge) in patients undergoing major 3+ level lumbar spinal fusion procedures.
      Additionally, cytokine markers, pain scores and additional pain medication requirements
      associated with surgery will be measured.
    

Intervention name(s): Dexmedetomidine; 0.9% Saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.; Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar Fusion; Inflammation; Dexmedetomidine; Length of Hospital Stay; General Anesthesia; Anti-inflammatory; GPCR; Cytokine; Immune Response