NCT02854904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

July 26, 2016

Last Update Submit

August 22, 2016

Conditions

Spine; ArthrosisSpondylolysisSpondylolysis, Multiple Sites in SpineSpondylolisthesis

Keywords

Immunomodulatorydexmedetomidineanesthesiaalpha-2 agonistarthrodesisspinal fusionImmune effectdouble randomized clinical trials

Outcome Measures

Primary Outcomes (3)

  • Changes from baseline of anti-inflammatory activity

    Measure of release pro-inflammatory cytokines \[interleukin 1-beta (IL-1b), interleukin 6 (IL-6) and tumoral necrosis factor alpha (TNF-a)\]

    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

  • Changes from baseline of cellular and humoral T-helper cells activity

    Serum dosage of interferon-gamma and interleukin 4 (IL-4)

    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

  • The endocrine-metabolic changes

    Serum dosage of cortisol, insulin and glucose

    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

Study Arms (2)

Dexmedetomidine intervention

EXPERIMENTAL

Dexmedetomidine (1 ug/kg/hr) during anesthesia.

Drug: Dexmedetomidine intervention

Placebo

PLACEBO COMPARATOR

Infusion of normal saline during anesthesia.

Drug: Placebo

Interventions

Dexmedetomidine interventionDRUG

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.

Also known as: Alpha-2 agonist, Precedex
Dexmedetomidine intervention
PlaceboDRUG

Placebo controlled

Also known as: Comparator
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luciano Pereira Miranda

Brasília, Federal District, 70673103, Brazil

RECRUITING

MeSH Terms

Conditions

OsteoarthritisSpondylolysisSpondylolisthesisAnkylosis

Interventions

Adrenergic alpha-2 Receptor AgonistsDexmedetomidine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSpondylosisSpinal DiseasesBone Diseases

Intervention Hierarchy (Ancestors)

Adrenergic alpha-AgonistsAdrenergic AgonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luciano P Miranda

    Sarah Network of Rehabilitation Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Miranda

CONTACT

+5561981866185mirandalp@uol.com.br

Luciano Miranda

CONTACT

6181866185mirandalp@uol.com.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 4, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

June 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-08

Locations

BR(1)