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

NCT04435925 | Completed

• 1 other identifier: UNUD-CTR-FK110620-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Disease; Anesthesia; Inflammatory Response

Outcome Measures

Primary Outcomes (10)

• Epinephrine

  Serum epinephrine level

  1-hour (postoperative)

• Epinephrine

  Serum epinephrine level

  24-hours (postoperative)

• Norepinephrine

  Serum norepinephrine level

  1-hour (postoperative)

• Norepinephrine

  Serum norepinephrine level

  24-hours (postoperative)

• PLR

  platelet-to-lymphocyte ratio

  1-hour (postoperative)

• PLR

  platelet-to-lymphocyte ratio

  24-hours (postoperative)

• LMR

  lymphocyte-to-monocyte ratio

  1-hour (postoperative)

• LMR

  lymphocyte-to-monocyte ratio

  24-hours (postoperative)

• Glucose

  serum glucose level

  1-hour (postoperative)

• Glucose

  serum glucose level

  24-hours (postoperative)

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia.

Drug: Remifentanil

Fentanyl

PLACEBO COMPARATOR

Patients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia.

Drug: Fentanyl

Interventions

Remifentanil DRUG

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

Remifentanil

Fentanyl DRUG

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

Fentanyl

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

MeSH Terms

Conditions

Breast Diseases

Interventions

Remifentanil; Fentanyl

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• I Gusti AG Hartawan

  Udayana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-blind, randomized control trial. It provides a controlled treatment of general anesthesia with an opioid regimen between remifentanil and fentanyl.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: July 27, 2020
• Primary Completion: December 30, 2020
• Study Completion: April 30, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)