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

Primary Purpose

Breast Disease, Anesthesia, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Remifentanil
Fentanyl
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Disease

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sanglah General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Remifentanil

Fentanyl

Arm Description

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

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

Outcomes

Primary Outcome Measures

Epinephrine
Serum epinephrine level
Epinephrine
Serum epinephrine level
Norepinephrine
Serum norepinephrine level
Norepinephrine
Serum norepinephrine level
PLR
platelet-to-lymphocyte ratio
PLR
platelet-to-lymphocyte ratio
LMR
lymphocyte-to-monocyte ratio
LMR
lymphocyte-to-monocyte ratio
Glucose
serum glucose level
Glucose
serum glucose level

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
May 30, 2021
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT04435925
Brief Title
Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
Official Title
Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Disease, Anesthesia, Inflammatory Response

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
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.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia.
Arm Title
Fentanyl
Arm Type
Placebo Comparator
Arm Description
Patients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes
Primary Outcome Measure Information:
Title
Epinephrine
Description
Serum epinephrine level
Time Frame
1-hour (postoperative)
Title
Epinephrine
Description
Serum epinephrine level
Time Frame
24-hours (postoperative)
Title
Norepinephrine
Description
Serum norepinephrine level
Time Frame
1-hour (postoperative)
Title
Norepinephrine
Description
Serum norepinephrine level
Time Frame
24-hours (postoperative)
Title
PLR
Description
platelet-to-lymphocyte ratio
Time Frame
1-hour (postoperative)
Title
PLR
Description
platelet-to-lymphocyte ratio
Time Frame
24-hours (postoperative)
Title
LMR
Description
lymphocyte-to-monocyte ratio
Time Frame
1-hour (postoperative)
Title
LMR
Description
lymphocyte-to-monocyte ratio
Time Frame
24-hours (postoperative)
Title
Glucose
Description
serum glucose level
Time Frame
1-hour (postoperative)
Title
Glucose
Description
serum glucose level
Time Frame
24-hours (postoperative)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I Gusti AG Hartawan
Organizational Affiliation
Udayana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanglah General Hospital
City
Denpasar
State/Province
Bali
ZIP/Postal Code
80114
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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