Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
Condition: Breast Disease; Anesthesia; Inflammatory Response
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Remifentanil; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute; Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-blind, randomized control trial. It provides a controlled treatment of general anesthesia with an opioid regimen between remifentanil and fentanyl.
Masking: Single (Participant)
Primary purpose: Supportive Care