Immune Effect of Dexmedetomidine as Immunomodulatory Anesthesic Agent in Patients Undergoing to Spinal Fusion: a Double-blind, Randomized and Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Changes from baseline of cellular and humoral T-helper cells activity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III;
- •Age > 18;
- •Elective surgery to spinal fusion, and;
- •Informed consent signed.
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine intervention
Dexmedetomidine (1 ug/kg/hr) during anesthesia.
干预措施: Dexmedetomidine intervention (Drug)
Placebo
Infusion of normal saline during anesthesia.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline of cellular and humoral T-helper cells activity
时间窗: 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
时间窗: 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
Changes from baseline of anti-inflammatory activity
时间窗: 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 \[interleukin 1-beta (IL-1b), interleukin 6 (IL-6) and tumoral necrosis factor alpha (TNF-a)\]
次要结局
未报告次要终点
研究者
Luciano Pereira Miranda
MD
Sarah Network of Rehabilitation Hospitals