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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435925
• Other study ID #: UNUD-CTR-FK110620-001
• Status: Completed
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Udayana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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 ß blockers medication

• History of diabetes, autoimmune disease, or heart disease

Related Conditions & MeSH terms

• Anesthesia
• Breast Disease
• Breast Diseases
• Inflammatory Response

Intervention

Drug:
• Remifentanil
Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute
• Fentanyl
Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes

Locations

Country	Name	City	State
Indonesia	Sanglah General Hospital	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epinephrine	Serum epinephrine level	1-hour (postoperative)
Primary	Epinephrine	Serum epinephrine level	24-hours (postoperative)
Primary	Norepinephrine	Serum norepinephrine level	1-hour (postoperative)
Primary	Norepinephrine	Serum norepinephrine level	24-hours (postoperative)
Primary	PLR	platelet-to-lymphocyte ratio	1-hour (postoperative)
Primary	PLR	platelet-to-lymphocyte ratio	24-hours (postoperative)
Primary	LMR	lymphocyte-to-monocyte ratio	1-hour (postoperative)
Primary	LMR	lymphocyte-to-monocyte ratio	24-hours (postoperative)
Primary	Glucose	serum glucose level	1-hour (postoperative)
Primary	Glucose	serum glucose level	24-hours (postoperative)