Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
1 other identifier
interventional
66
1 country
2
Brief Summary
The aim of the proposed study is to examine the effect of DEX on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
December 14, 2016
CompletedJuly 11, 2017
June 1, 2017
1.3 years
January 3, 2011
March 14, 2016
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Recovery Score (QoR-40)
The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Post-operative Day 3
Secondary Outcomes (4)
Concentration of TNF-alpha
Post-operative Day 1
Concentration of IL-1a
Post-operative Day 1
Concentration of IL-6
Post-operative Day 1
Concentration of IL-8
Post-operative Day 1
Study Arms (2)
Placebo group
PLACEBO COMPARATOREligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Dexmedetomidine group
EXPERIMENTALEligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Interventions
Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Eligibility Criteria
You may qualify if:
- Adult (\> 18) male or female who will undergo surgery for spinal fusion with general anesthesia.
- If female, subject is non-lactating and is either:
- Not of childbearing potential
- Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
- Subject is ASA physical status 1, 2, or 3.
You may not qualify if:
- Cognitively impaired (by history)
- Subject requires chronic antipsychotic history
- Subject is anticipated to require an additional surgery within 90 days after the intended spinal fusion
- Subject known to be in liver failure
- Subject has received treatment with alpha-2-agonist or antagonist within 2 weeks of study entry
- Subject for whom opiates, benzodiazepines, DEX are contraindicated
- Chronic use of steroids/NSAIDs
- Patients with serious bradycardia related arrhythmias, i.e. 2nd degree block.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NYU Langone Medical Center, Department of Anesthesiology
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Related Publications (1)
Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.
PMID: 22824921RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alex Bekker
- Organization
- UMDNJ-New Jersey Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Bekker, MD, PhD
NYU School of Medicine
- PRINCIPAL INVESTIGATOR
Michael Urban, MD
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2011
First Posted
June 21, 2011
Study Start
September 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 11, 2017
Results First Posted
December 14, 2016
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share