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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00808665 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Fusion |
Drug: Intravenous infusion of Dexmedetomidine or 0.9% Saline |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
| Official Title: | Does Continuous Perioperative Dexmedetomidine Infusion Reduce Time to Discharge in Patients Undergoing Major Lumbar Fusion? A Double-Blind, Placebo-Controlled Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Dexmedetomidine: Experimental
Patients will receive an intravenous bolus and infusion of dexmedetomidine before and during lumbar spinal fusion surgery. Infusion will continue for four hours postoperatively.
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Drug: Intravenous infusion of Dexmedetomidine or 0.9% Saline
Patients will be given a bolus of 1 mcg/kg of dexmedetomidine over 15 minutes prior to surgery which will be followed a continuous infusion of 0.6 mcg/kg of dexmedetomidine during the first three hours of surgery. Dexmedetomidine dose will be reduced to 0.4 mcg/kg 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 at the same points and over the same periods. Drug administration will be controlled in volumes for both arms.
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Saline: Placebo Comparator
Patients will receive a bolus and infusion of saline intravenously before and during lumbar spinal fusion surgery. Infusion will be continued for four hours after surgery.
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Drug: Intravenous infusion of Dexmedetomidine or 0.9% Saline
Patients will be given a bolus of 1 mcg/kg of dexmedetomidine over 15 minutes prior to surgery which will be followed a continuous infusion of 0.6 mcg/kg of dexmedetomidine during the first three hours of surgery. Dexmedetomidine dose will be reduced to 0.4 mcg/kg 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 at the same points and over the same periods. Drug administration will be controlled in volumes for both arms.
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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 inflammation - 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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | James L Blair, DO | Vanderbilt University |
More Information
| Responsible Party: | Department of Anesthesiology Vanderbilt University Medical Center ( James L. Blair, DO ) |
| Study ID Numbers: | IRB-081331 |
| Study First Received: | December 15, 2008 |
| Last Updated: | December 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00808665 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Lumbar Fusion Inflammation Dexmedetomidine Length of Hospital Stay General Anesthesia |
Anti-inflammatory GPCR Cytokine Immune Response |
|
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Analgesics, Non-Narcotic Hypnotics and Sedatives Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Analgesics Dexmedetomidine Adrenergic Agonists Inflammation |
|
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Adrenergic Agonists |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents |
