Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion

NCT00808665 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-081331
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Fusion Acquired; Spinal Stenosis; Lesions of Lumbosacral Intervertebral Disc; Spinal Diseases

Keywords

Lumbar Fusion; Inflammation; Dexmedetomidine; Length of Hospital Stay; General Anesthesia; Anti-inflammatory; GPCR; Cytokine; Immune Response

Outcome Measures

Primary Outcomes (1)

• Time Required After Surgery to Reach Fitness for Discharge From Hospital

  Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Saline

PLACEBO COMPARATOR

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.

Drug: 0.9% Saline

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

0.9% Saline DRUG

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.

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Classification I - III
• Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• 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.

  PMID: 18685927 BACKGROUND

• Sanders RD, Maze M. Alpha2-adrenoceptor agonists. Curr Opin Investig Drugs. 2007 Jan;8(1):25-33.

  PMID: 17263182 BACKGROUND

• 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.

  PMID: 15464093 BACKGROUND

• 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.

  PMID: 12552203 BACKGROUND

• 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.

  PMID: 8638842 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Spinal Diseases; Inflammation

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: James Blair DO
• Organization: Vanderbilt University Medical Center

james.l.blair@vanderbilt.edu

615-343-6082

Study Officials

• James L Blair, DO

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-05

Locations

US (1)