Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Glucose
研究概览
简要总结
Mastectomy triggers stress and inflammation responses due to tissue trauma. Surgical stress will increase levels of hormones (adrenocorticotropic hormone, cortisol, antidiuretic hormone, epinephrine, norepinephrine, and dopamine) and inflammatory cytokines (Tumor Necrotic Factor-α, interleukin-1, interleukin-2, and interleukin-6) in the body. This causes insulin resistance, gluconeogenesis, and glycolysis, and impaired insulin secretion, which results in hyperglycemia due to intraoperative stress. Intraoperative hyperglycemia increases postoperative complications and mortality. Inhibition of hyperglycemia due to operative stress and stress hormones with good anesthetic management in improving patient outcomes.
The choice of opioid type plays an important role in suppressing the perioperative stress and inflammatory response. Opioids are an alternative, besides the use of regional anesthetic techniques which have been proven to suppress the perioperative stress response. Fentanyl is one of the phenylpiperidine synthetic opioids. Large doses of fentanyl can reduce stress responses but also increase side effects, such as hemodynamic instability and decrease T-cell function.
Remifentanil provides unique pharmacokinetic benefits through nonspecific esterase enzyme metabolism, so it has a very fast onset and half-life. In addition, remifentanil also provides benefits in reducing the production of interleukin 6 cytokines (IL-6) and tumor necrosis factor α (TNF-α) and inhibits neutrophil migration through the endothelial layer.
The stress response to stress and inflammation is directly proportional to the dose of remifentanil given. It is reported that remifentanil can suppress cortisol response according to increasing dose.
Winterhalter et al. and Lee et al. reported that remifentanil is better at suppressing the stress response than fentanyl. On the other hand, Bell et al. showed no difference in cortisol and hemodynamic levels between the two groups.
The goal of this study is to see if remifentanil provides less increase in serum epinephrine level, norepinephrine level, platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR), and blood glucose level at one-hour and 24-hours postoperative in patients undergoing mastectomy surgery under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The opioid selection disguised to the patient. Eligible subjects will be randomized so that each research subject has the same opportunity to be included in both groups.
入排标准
- 年龄范围
- 30 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for a mastectomy under general anesthesia
- •Patients aged 30-65 years old
- •ASA physical status: I-II
排除标准
- •Refusal to be included in the study
- •History of opioid allergies
- •Long-term use of steroids
- •Patients on β blockers medication
- •History of diabetes, autoimmune disease, or heart disease
研究组 & 干预措施
Remifentanil
Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia.
干预措施: Remifentanil (Drug)
Fentanyl
Patients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Glucose
时间窗: 24-hours (postoperative)
serum glucose level
Epinephrine
时间窗: 24-hours (postoperative)
Serum epinephrine level
Norepinephrine
时间窗: 24-hours (postoperative)
Serum norepinephrine level
PLR
时间窗: 24-hours (postoperative)
platelet-to-lymphocyte ratio
LMR
时间窗: 24-hours (postoperative)
lymphocyte-to-monocyte ratio
次要结局
未报告次要终点
研究者
Christopher Ryalino
Principal Investigator
Udayana University
