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Completed

NCT Number: NCT04435925

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

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.

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Key information

Conditions

Breast Disease Anesthesia Breast Diseases Inflammatory Response Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. Epinephrine

    Time frame: 1-hour (postoperative)

    Serum epinephrine level

  2. Epinephrine

    Time frame: 24-hours (postoperative)

    Serum epinephrine level

  3. Norepinephrine

    Time frame: 1-hour (postoperative)

    Serum norepinephrine level

  4. Norepinephrine

    Time frame: 24-hours (postoperative)

    Serum norepinephrine level

  5. PLR

    Time frame: 1-hour (postoperative)

    platelet-to-lymphocyte ratio

  6. PLR

    Time frame: 24-hours (postoperative)

    platelet-to-lymphocyte ratio

  7. LMR

    Time frame: 1-hour (postoperative)

    lymphocyte-to-monocyte ratio

  8. LMR

    Time frame: 24-hours (postoperative)

    lymphocyte-to-monocyte ratio

  9. Glucose

    Time frame: 1-hour (postoperative)

    serum glucose level

  10. Glucose

    Time frame: 24-hours (postoperative)

    serum glucose level

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 17, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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