Clinical trial NCT04435925: Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
Official title: Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Disease
Anesthesia
Inflammatory Response
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 48
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a mastectomy under general anesthesia
* Patients aged 30-65 years old
* ASA physical status: I-II

Exclusion Criteria:

* 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

Primary outcomes:
measure: Epinephrine
timeFrame: 1-hour (postoperative)
measure: Epinephrine
timeFrame: 24-hours (postoperative)
measure: Norepinephrine
timeFrame: 1-hour (postoperative)
measure: Norepinephrine
timeFrame: 24-hours (postoperative)
measure: PLR
timeFrame: 1-hour (postoperative)
measure: PLR
timeFrame: 24-hours (postoperative)
measure: LMR
timeFrame: 1-hour (postoperative)
measure: LMR
timeFrame: 24-hours (postoperative)
measure: Glucose
timeFrame: 1-hour (postoperative)
measure: Glucose
timeFrame: 24-hours (postoperative)
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Sanglah General Hospital
state: Bali
Study officials:
affiliation: Udayana University
name: I Gusti AG Hartawan
role: PRINCIPAL_INVESTIGATOR
References: