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临床试验/NCT04435925
NCT04435925已完成不适用

Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia

Udayana University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年7月27日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia.

干预措施: Remifentanil (Drug)

Fentanyl

Placebo Comparator

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

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Ryalino

Principal Investigator

Udayana University

研究点 (1)

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