- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00808665
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion (DEXREDLOS)
Does Continuous Perioperative Dexmedetomidine Infusion Reduce Time to Discharge in Patients Undergoing Major Lumbar Fusion? A Double-Blind, Placebo-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Classification I - III
- Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels
Exclusion Criteria:
- Allergy to dexmedetomidine
- Cardiac disease with reduced ejection fraction < 30%
- History of cirrhosis, active hepatitis or attenuated hepatic function
- Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins
- Current anticoagulant therapy
- Patients requiring motor evoked potential (MEP) monitoring
- Positive pregnancy test
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexmedetomidine
At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
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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.
Other Names:
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Placebo Comparator: Saline
Since this is a blinded study, at the beginning of spinal surgery, patients will receive a 1 hour 0.9% saline intravenous bolus at a rate and volume commensurate with a 0.7 mcg/kg/hour bolus of dexmedetomidine.
Similarly, this will be followed with a saline infusion at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of saline at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time Required After Surgery to Reach Fitness for Discharge From Hospital
Time Frame: Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)
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Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)
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Collaborators and Investigators
Investigators
- Principal Investigator: James L Blair, DO, Vanderbilt University
Publications and helpful links
General Publications
- Nelson LE, Lu J, Guo T, Saper CB, Franks NP, Maze M. The alpha2-adrenoceptor agonist dexmedetomidine converges on an endogenous sleep-promoting pathway to exert its sedative effects. Anesthesiology. 2003 Feb;98(2):428-36. doi: 10.1097/00000542-200302000-00024.
- Taniguchi T, Kurita A, Kobayashi K, Yamamoto K, Inaba H. Dose- and time-related effects of dexmedetomidine on mortality and inflammatory responses to endotoxin-induced shock in rats. J Anesth. 2008;22(3):221-8. doi: 10.1007/s00540-008-0611-9. Epub 2008 Aug 7.
- Sanders RD, Maze M. Alpha2-adrenoceptor agonists. Curr Opin Investig Drugs. 2007 Jan;8(1):25-33.
- Ma D, Hossain M, Rajakumaraswamy N, Arshad M, Sanders RD, Franks NP, Maze M. Dexmedetomidine produces its neuroprotective effect via the alpha 2A-adrenoceptor subtype. Eur J Pharmacol. 2004 Oct 11;502(1-2):87-97. doi: 10.1016/j.ejphar.2004.08.044.
- Guo TZ, Jiang JY, Buttermann AE, Maze M. Dexmedetomidine injection into the locus ceruleus produces antinociception. Anesthesiology. 1996 Apr;84(4):873-81. doi: 10.1097/00000542-199604000-00015.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Bone Diseases
- Spinal Diseases
- Spinal Stenosis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- IRB-081331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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