Spondylolisthesis Clinical Trial
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
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.
PURPOSE
Interactions between the hypothalamus-pituitary-adrenal axis, sympathetic nervous system and
immunological system acts in the initiation and propagation to reactions of trauma distress.
A large number of factors affect the activation of immune response owing to surgical trauma
and anesthesia. Regarding the current field, surveys are need to evaluate the real clinical
significance of immune control.
In order to blunt the surgical stress response, the control of inflammatory response is
considered by many authors the most important factor. Therefore, dexmedetomidine as an
immunomodulatory anesthesic agent plays a way to more effective control to the endocrine
metabolic response, predicate role to better outcomes in patients undergoing to major
surgical trauma.
This trial is designed as a double-blind, randomized and placebo-controlled to evaluate the
utility of dexmedetomidine as immunomodulatory anesthetic agent in a major surgical model.
HYPOTHESIS
Dexmedetomidine provide more effective immune control at general anesthesia in patients
undergoing to spine fusion.
OBJECTIVES
Goals standard to immune control, hemodynamic safety and recovery quality.
1. Measure of release pro-inflammatory cytokines [interleukin 1-beta (IL-1b), interleukin
6 (IL-6) and tumoral necrosis factor alpha (TNF-a)] to evaluate the anti-inflammatory
activity in vivo of dexmedetomidine;
2. Serum dosage of interferon-gamma and interleukin 4 (IL-4) to evaluate changes of
cellular and humoral T-helper cells activity;
3. Endocrine-metabolic changes will be evaluated with the dosage serum cortisol, insulin
and glucose;
4. Hemodynamic safety will be performed with a vital signals and changes of ventricular
stress and myocardium ischemia markers [brain natriuretic pro-peptide (pro-BNP),
troponin I and creatine kinase (CK-MB)];
5. Renal function will be evaluated with measure diuresis rate, fluid balance, serum
levels of Cystatin-C, electrolytes [sodium and potassium] and arterial blood gas;
6. Time to open eyes after turn off anesthesic gases to evaluate the wake-up time (time to
recovery of consciousness (ROC);
7. Partial pressure of carbon dioxide (CO2) and respiratory rate immediately after the end
of anesthesia to evaluate a respiratory changes;
8. Ricker Sedation-Agitated Scale and Visual Analogic Pain Scale will be performed after
15 minutes on arrival of patients at the recovery room;
9. The QoR-40 (quality of recovery - 40) questionnaire before the surgery and the first
postoperative day to a quality support;
10. The incidence of nausea, vomiting, hypotension, hypertension, bleeding, bradycardia and
tachycardia will be recorded during surgery and in a pos anesthetic period.
RESEARCH METHOD
A randomized double-blind clinical trial was elaborated to compare two groups of patients,
active dexmedetomidine group (Dexmedetomidine group - SD) and placebo comparator (Placebo
group - SP). For our knowledge, our proposal study was approved by the Ethnic Committee of
the Sarah Network of Rehabilitation Hospitals since June of 2016 (Approval Number:
50057415.0.0000.0022). All patients who will be enrolled to our study must sign informed
consent.
Once schedule spinal fusion, patients both sex, 18 to 75 years old and physical state (ASA)
1-3 will be enrolled in this trial. All patients will be evaluated in the anesthesic
ambulatory. Then, the patients will be randomly divided blindly into Group SD or Group SP.
In the pre-anesthesic room, patients will be monitored with electrocardiography, non
invasive blood pressure, pulse oximetry and entropy. After peripheral venous access
obtained, the first sample (Time 0: Before induction of anesthesia) can be taken and start
dexmedetomidine or placebo dripping.
According to a clinic demand, anesthesia will be performed with propofol, rocuronium,
fentanyl, methadone and/or remifentanyl. After endotracheal access, the lungs will be
ventilated with oxygen in air (1:2), and the ventilation rate will be adjusted to maintain
the end-tidal carbon dioxide partial pressure between 35 and 45 mmHg. The concentrations of
sevoflurane will be adjusted for maintain hypnosis entropy score between 40 and 45.
Invasive blood pressure through radial artery will be obtained. The samples of blood will be
retrieved from arterial line at three moments: Time 1: 8h after the end of surgery; Time 2:
7:00h AM, 24h after the first sample have been collected, and; Time 3: 7:00h AM, 48h after
the first sample have been collected.
In the SD group, dripping of dexmedetomidine (0.2 - 1 ug/kg/hr) will be administered during
surgery. Already in the SP group, normal saline will be administered with same rate as a
placebo.
Effective site concentration of anesthesics drugs will be adjusted for maintain entropy
between 40 and 45 and changes of vital sign between 20% of baseline value. On line
sevoflurane concentrations using an infrared anesthetic gases analyzer.
After the end of surgery, all anesthetics agents will be discontinued and the time to
wake-up will be recorded. Patients will be asked to open their eyes and the time of eyes
open will be recorded. After the eyes open, the patients will be transferred to recovery
room.
After arrival on the recovery room, blood pressure, heart rate, Ricker Sedation-Agitated
Scale and Visual Analogic Pain Scale will be measure in the first 15 minutes and in the
leave of recovery room. The time of staying in postanesthetic care unit is recorded.
The incidence of nausea, vomiting, hypotension, hypertension, bleeding, bradycardia and
tachycardia will be recorded during surgery and staying at postanesthetic care unit. All
participants will be followed for the duration of surgery and postanesthetic period.
STATISTICAL ANALYSIS
All data will be expressed as mean ± standard deviation or absolute values. The Student's
t-test or Mann-Whitney U-test to performed to demographic data.
The Wilcoxon rank-sun test to compare cytokines concentrations and scores of quality between
groups at the time points. Friedman's test will be performed to compare cytokine or clinical
markers among each time points groups. Dunn's pos hoc test for statistic significance.
Recovery and quality profiles [time to recovery of consciousness (ROC); Ricker
sedation-agitated scale at the postanesthetic care unit and; QoR-40] will be analyzed by
paired t-test.
The incidence of nausea/vomiting, hypotension, hypertension, bleeding, bradycardia, and
tachycardia will be analyzed by Chi-square test.
All analyses will be performed using SPSS version 15.0 software for Windows. A P-value <
0.05 will be deemed to a statistical significance.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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