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Trial record 2 of 2 for:    "Spondylolisthesis" | "Dexmedetomidine"

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
Sponsor:
Collaborator:
University of Brasilia
Information provided by (Responsible Party):
Luciano Pereira Miranda, Sarah Network of Rehabilitation Hospitals

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Alpha-2 agonist
  • Precedex

Placebo Comparator: Placebo
Infusion of normal saline during anesthesia.
Drug: Placebo
Placebo controlled
Other Name: Comparator




Primary Outcome Measures :
  1. 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)]

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III;
  • Age > 18;
  • Elective surgery to spinal fusion, and;
  • Informed consent signed.

Exclusion Criteria:

  • Patients with severe heart disease with New York Heart Association class > III;
  • Severe arrhythmia;
  • Uncontrolled hypertension or hypotension;
  • Hemodynamic unstably;
  • Hypersensitivity with drugs;
  • Cognitive deficiency, dementia, or delirium;
  • Weight up to 100 kg and/or body mass index (BMI) greater than or equal to 40;
  • Illicit drugs users and/or alcoholic;
  • Steroids and/or non-steroids anti-inflammatory chronic users;
  • Tricyclic antidepressants users;
  • Hepatic or renal compromised and;
  • Infective disease.

Information from the National Library of Medicine

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


Contacts
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Contact: Luciano Miranda +5561981866185 mirandalp@uol.com.br
Contact: Luciano Miranda 6181866185 mirandalp@uol.com.br

Locations
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Brazil
Luciano Pereira Miranda Recruiting
Brazilia, Federal District, Brazil, 70673103
Contact: Luciano P Miranda    +5561981866185    mirandalp@uol.com.br   
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         
Sponsors and Collaborators
Sarah Network of Rehabilitation Hospitals
University of Brasilia
Investigators
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Principal Investigator: Luciano P Miranda Sarah Network of Rehabilitation Hospitals

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Responsible Party: Luciano Pereira Miranda, MD, Sarah Network of Rehabilitation Hospitals
ClinicalTrials.gov Identifier: NCT02854904     History of Changes
Other Study ID Numbers: NRH1
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Cause the study not yet start.
Keywords provided by Luciano Pereira Miranda, Sarah Network of Rehabilitation Hospitals:
Immunomodulatory
dexmedetomidine
anesthesia
alpha-2 agonist
arthrodesis
spinal fusion
Immune effect
double randomized clinical trials
Additional relevant MeSH terms:
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Spondylolisthesis
Dexmedetomidine
Joint Diseases
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Adrenergic alpha-2 Receptor Agonists
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action