Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pain

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Propofol

Remifentanil

Desflurane

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

The patients will recieve intravenous anesthesia (propofol-remifentanyl)

Recommended dosage:

Propofol: Induction dosage 1,5-2,5 mg/kg Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

The patients will recieve volatile anesthesia (desflurane-remifentanyl)

Recommended dosage:

Desflurane dosage 6-7 MAC Remifentanyl: Induction dosage 0,5-1μg/min The preservation dosage will depend from patients' body weight, body height and BMI

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil)

Evangelos Konstantinou, RN, PhD

The aim of the present study is to investigate the effect of intravenous anesthetics versus the administration of volatile anesthetics on stress and pain levels during autologous fat transfer for breast reconstruction in a Day Care Center.

The sample of the study will be patients who will have Autologous Fat Transfer for Breast Reconstruction.

Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while the DES group (N = 23) volatile anesthetics (desflurane-remifentanil).

Specifically, the TIVA group will include patients over 50 years of age with high risk of nausea / vomiting and postoperative delirium, as well as suspicion of malignant hyperthermia. Patients with cardiac and respiratory problems will be included in the DES group.

The following data will be collected in the Data Sheet: Patient Demographics (Gender, Age), Body Mass Index (Body Height- Body Weight). Simultaneously, the pain levels will be evaluated by VAS Optical Analogue Scale of VAS 0-10 in PACU, preoperatively and postoperatively, and perioperative pain levels will be assessed with CPOT scale (values 0-8).

Stress levels will be evaluated with 3 NAS questions: a. How sad do you feel right now? b. How anxious do you feel right now? and c. How optimistic do you feel right now?. The 3 NAS questions will also be given preoperatively and postoperatively to the ward. The sedation levels will be assessed by RASS scale (values +4 to -5) and the Bispectral Index (BIS). The level of patient's awareness will be assessed by GCS Scale (3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)).

The presence or absence of nausea / vomiting and the appearance of immediate postoperative complications will be examined. Finally, post-operative stress will be examined with stress biomarkers, salivary ACTH hormone and salivary cortisol hormone.

TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction

TIVA Versus Volatile Anesthetics Admnistration on Stress and Pain Levels During Autologous Fat Transfer in Breast Reconstruction, in a Day Care Center

Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples.

Analyzing Cortisol and Adrenocorticotropic hormones levels in salivary samples in patients after breast recostruction in a day care center.

These measures will occured in three phases a. preoperatively, b. perioperatively c. in the PACU phase.

Evaluating perioperative pain levels between the two protocols with scale such as Critical Care Pain Observational Tool (CPOT scale, range 0-8(with a score of 0 = None and 8 = severe pain) )

Evaluating perioperative stress levels between the two protocols with scale, such as the self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how sad are you feeling?in two phases: a. preoperatively, b) in PACU

Evaluation with Richmond Agitation-Sedation Scale (RASS scale, range +4 to -5, (with a score of -5 = unarousable and +4 = violent, immediate danger for the staff) ).

Evaluation with Bispectral index (BIS, range 0-100). A BIS score quantifies changes in the electrophysiologic state of the brain during anesthesia. In patients who are awake, a typical BIS score is 90 to 100. Complete suppression of cortical activity results in a BIS score of 0, known as a flat line. Lower numbers indicate a higher hypnotic effect. Overall, a BIS value below 60 is associated with a low probability of response to commands.

Evaluating perioperative pain levels between the two protocols with scale such as Visual analogu pain scale (VAS, range 0-10, (with a score of 0 = None and 10 = severe pain) ) in PACU

Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how stressed are you feeling, in two phases: a. preoperatively, b) in PACU

Evaluating perioperative stress levels between the two protocols with scale, such as three self-experienced questions (range0-10, (with a score of 0 = None and 10 = Completely) ) how optimistic are you feeling, in two phases: a. preoperatively, b) in PACU

Saint Savvas Anticancer Hospital

National and Kapodistrian University of Athens

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Aspiration

Breast Diseases

Skin Diseases

Respiration Disorders

Respiratory Tract Diseases

Platelet Aggregation Inhibitors

Sevoflurane

induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery

propofol-based total intravenous anesthesia during breast cancer surgery

Valerii Subbotin, PhD

Kristina Kadantseva

Kristina Kadantseva, MD

Valery Likhvantsev, PhD

Even decade ago it was believed that the choice method of anesthesia did not affect the course of the oncological process, but recent evidence has begun to emerge that inhalation anesthesia vs TIVA is associated with a higher number of adverse outcomes. Apparently, it makes sense to conduct mRCT in order to assess the effect of IA on immune system in patients operated on for breast cancer comprehensively. The results of that kind of RCT may finally give us an answer whether the choice of anesthesia affects the immune status of patients undergoing surgery for breast cancer. The evaluation of complications and long-term survival will allow to recommend to use or not to use IA for this type of surgery.

Objective: The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery

The power calculation for this study was based on an assessment of Neutrophil-lymphocyte ratio (NLR) in patients undergoing breast cancer resection with total intravenous and inhalation anesthesia in two studies:

1. Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46)
2. Ní Eochagáin A. et al., 2018 - 116 patients (PMID: 29457215, TIVA group: NLR = 3.20 ± 1.37; inhalation group: NLR = 4.10 ± 1.90).

The pooled mean NLR in the TIVA group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78.

Difference in means (effect size): 0.78, for level α=0.05, power 1-β=80% and expected standard deviation of 1.5, 65 patients in each group should be recruited, taking into account a 10% margin (total number of patients: 130).

The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.

The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial (TeMP - Trial).

Absolute number of neutrophils divided by the absolute number of lymphocytes

the ratio of T helper cells to cytotoxic T cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction	NCT04077827	Breast Cancer	Propofol	20 Years - 70 Years	National and Kapodistrian University of Athens
TIVA Admnistration and Autologous Fat Transfer in Breast Reconstruction	NCT04077827	Breast Cancer	Propofol	20 Years - 70 Years	National and Kapodistrian University of Athens
The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.	NCT04800393	Anesthesia Breast Cancer	Sevoflurane Propofol	45 Years - 74 Years	Moscow Clinical Scientific Center
The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial.	NCT04800393	Anesthesia Breast Cancer	Sevoflurane Propofol	45 Years - 74 Years	Moscow Clinical Scientific Center

Spots Global Cancer Trial Database for volatile anesthesia