Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
- Conditions
- Breast DiseaseAnesthesiaInflammatory Response
- Interventions
- Registration Number
- NCT04435925
- Lead Sponsor
- Udayana University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
- Patients scheduled for a mastectomy under general anesthesia
- Patients aged 30-65 years old
- ASA physical status: I-II
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fentanyl Fentanyl Patients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia. Remifentanil Remifentanil Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia.
- Primary Outcome Measures
Name Time Method LMR 24-hours (postoperative) lymphocyte-to-monocyte ratio
Glucose 24-hours (postoperative) serum glucose level
PLR 24-hours (postoperative) platelet-to-lymphocyte ratio
Epinephrine 24-hours (postoperative) Serum epinephrine level
Norepinephrine 24-hours (postoperative) Serum norepinephrine level
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanglah General Hospital
🇮🇩Denpasar, Bali, Indonesia