Spinal Stenosis Clinical Trial
Official title:
Does Continuous Perioperative Dexmedetomidine Infusion Reduce Time to Discharge in Patients Undergoing Major Lumbar Fusion? A Double-Blind, Placebo-Controlled Study
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.
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.
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