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

NCT ID: NCT04435925

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2021-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Remifentanil

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

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

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

Fentanyl

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

Group Type: PLACEBO_COMPARATOR

Fentanyl

Intervention Type: DRUG

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

Interventions

Remifentanil

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

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Ryalino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

I Gusti AG Hartawan

Role: PRINCIPAL_INVESTIGATOR

Udayana University

Locations

Sanglah General Hospital

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

UNUD-CTR-FK110620-001

Identifier Type: -

Identifier Source: org_study_id