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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04435925
Enrollment
48
Registered
2020-06-17
Start date
2020-07-27
Completion date
2021-04-30
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Breast Disease, Inflammatory Response

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.

Interventions

DRUGRemifentanil

Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute

DRUGFentanyl

Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes

Sponsors

Udayana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

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.

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.

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epinephrine1-hour (postoperative)Serum epinephrine level
Norepinephrine1-hour (postoperative)Serum norepinephrine level
PLR1-hour (postoperative)platelet-to-lymphocyte ratio
LMR1-hour (postoperative)lymphocyte-to-monocyte ratio
Glucose1-hour (postoperative)serum glucose level

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026