Immune Effect of Dexmedetomidine in Patients Undergoing to Spinal Fusion (eMUNODEX)
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|ClinicalTrials.gov Identifier: NCT02854904|
Recruitment Status : Unknown
Verified August 2016 by Luciano Pereira Miranda, Sarah Network of Rehabilitation Hospitals.
Recruitment status was: Recruiting
First Posted : August 4, 2016
Last Update Posted : August 23, 2016
Alpha-agonist in anesthesia display immunomodulatory effect in addition to antiadrenergic control. This effect of the immune system can be a key to a better perioperative safety and quality.
The association of dexmedetomidine at general anesthesia adds up organic protection and inflammatory control to a surgery trauma owing to antinociception and immunomodulatory effect.
The aim this study is evaluate if the association of dexmedetomidine at general anesthesia standing effective immunomodulatory control to trauma and improve changes at outcomes in patients undergoing to spinal fusion.
|Condition or disease||Intervention/treatment||Phase|
|Spine; Arthrosis Spondylolysis Spondylolysis, Multiple Sites in Spine Spondylolisthesis||Drug: Dexmedetomidine intervention Drug: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Immune Effect of Dexmedetomidine as Immunomodulatory Anesthesic Agent in Patients Undergoing to Spinal Fusion: a Double-blind, Randomized and Placebo-controlled Clinical Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Dexmedetomidine intervention
Dexmedetomidine (1 ug/kg/hr) during anesthesia.
Drug: Dexmedetomidine intervention
Immune effect of alpha-2 agonist to arthrodesis. Dexmedetomidine as a immune control anesthesic in patients undergoing to arthrodesis. Alpha-2 agonist to general anaesthesia.
Placebo Comparator: Placebo
Infusion of normal saline during anesthesia.
Other Name: Comparator
- Changes from baseline of anti-inflammatory activity [ Time Frame: Time 0: 7:00 AM, after obtained peripheral venous access; Time 1: 8h after the end of surgery; Time 2: 7:00h AM, 24h after the first sample have been collected; Time 3: 7:00h AM, 48h after the first sample have been collected ]Measure of release pro-inflammatory cytokines [interleukin 1-beta (IL-1b), interleukin 6 (IL-6) and tumoral necrosis factor alpha (TNF-a)]
- Changes from baseline of cellular and humoral T-helper cells activity [ Time Frame: Time 0: 7:00 AM, after obtained peripheral venous access; Time 1: 8h after the end of surgery; Time 2: 7:00h AM, 24h after the first sample have been collected; Time 3: 7:00h AM, 48h after the first sample have been collected ]Serum dosage of interferon-gamma and interleukin 4 (IL-4)
- The endocrine-metabolic changes [ Time Frame: Time 0: 7:00 AM, after obtained peripheral venous access; Time 1: 8h after the end of surgery; Time 2: 7:00h AM, 24h after the first sample have been collected; Time 3: 7:00h AM, 48h after the first sample have been collected ]Serum dosage of cortisol, insulin and glucose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854904
|Contact: Luciano Mirandafirstname.lastname@example.org|
|Contact: Luciano Mirandaemail@example.com|
|Luciano Pereira Miranda||Recruiting|
|Brazilia, Federal District, Brazil, 70673103|
|Contact: Luciano P Miranda +5561981866185 firstname.lastname@example.org|
|Sub-Investigator: Frankin C Paes|
|Sub-Investigator: Felipe R Bressan|
|Sub-Investigator: Frederico S da Silva Guimaraes|
|Sub-Investigator: Hebert D Nogueira|
|Sub-Investigator: Marisa M Jreige|
|Principal Investigator: Luciano P Miranda|
|Principal Investigator:||Luciano P Miranda||Sarah Network of Rehabilitation Hospitals|