Breast DiseaseNCT04435925
Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
A study testing Remifentanil and Fentanyl in people with Breast Disease and Anesthesia, run by Udayana University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Disease, Anesthesia, Inflammatory Response
- What is being tested?
- Remifentanil and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Jul 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for a mastectomy under general anesthesia
- Patients aged 30-65 years old
- ASA physical status: I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Remifentanil, Fentanyl
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute
FentanylDrug
Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Patients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia. Receives: Drug: Remifentanil |
| Fentanyl | Placebo comparator | Patients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epinephrine
Serum epinephrine level
Measured: 1-hour (postoperative)
Epinephrine
Serum epinephrine level
Measured: 24-hours (postoperative)
Norepinephrine
Serum norepinephrine level
Measured: 1-hour (postoperative)
Norepinephrine
Serum norepinephrine level
Measured: 24-hours (postoperative)
PLR
platelet-to-lymphocyte ratio
Measured: 1-hour (postoperative)
PLR
platelet-to-lymphocyte ratio
Measured: 24-hours (postoperative)
LMR
lymphocyte-to-monocyte ratio
Measured: 1-hour (postoperative)
LMR
lymphocyte-to-monocyte ratio
Measured: 24-hours (postoperative)
Glucose
serum glucose level
Measured: 1-hour (postoperative)
Glucose
serum glucose level
Measured: 24-hours (postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start27 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, Udayana University
- Investigators
- I Gusti AG Hartawan, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435925
- Sponsor's protocol ID
- UNUD-CTR-FK110620-001
- Status last verified
- May 2021
- First submitted
- 11 Jun 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04435925
- Acronym / sponsor ID
- UNUD-CTR-FK110620-001
- Conditions
- Breast Disease, Anesthesia, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: RemifentanilPatients assigned to this group will receive IV Remifentanil as an opioid for general anesthesia. |
| Fentanyl | Placebo comparator | Drug: FentanylPatients assigned to this group will receive IV Fentanyl as an opioid for general anesthesia. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for a mastectomy under general anesthesia
- Patients aged 30-65 years old
- ASA physical status: I-II
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilLoading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute | Drug | Remifentanil |
| FentanylLoading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes | Drug | Fentanyl |
Primary outcome
Epinephrine
Time frame: 1-hour (postoperative)
Serum epinephrine level
Epinephrine
Time frame: 24-hours (postoperative)
Serum epinephrine level
Norepinephrine
Time frame: 1-hour (postoperative)
Serum norepinephrine level
Norepinephrine
Time frame: 24-hours (postoperative)
Serum norepinephrine level
PLR
Time frame: 1-hour (postoperative)
platelet-to-lymphocyte ratio
PLR
Time frame: 24-hours (postoperative)
platelet-to-lymphocyte ratio
LMR
Time frame: 1-hour (postoperative)
lymphocyte-to-monocyte ratio
LMR
Time frame: 24-hours (postoperative)
lymphocyte-to-monocyte ratio
Glucose
Time frame: 1-hour (postoperative)
serum glucose level
Glucose
Time frame: 24-hours (postoperative)
serum glucose level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I Gusti AG Hartawan principal investigator
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and Fentanyl in people with Breast Disease and Anesthesia, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epinephrine (time frame: 1-hour (postoperative)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.