Neoplasms

Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Colorectal Neoplasms

Respiratory Aspiration

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Other Dietary Supplements

Anesthetics

Propofol

Isoflurane

Remifentanil

Benzocaine

Tannic Acid

* include 35 patients with colorectal cancer undergoing surgery
* anaesthesia is induced and maintained with total intravenous target-controlled infusion ( TIVA-TCI) of propofol and remifentanil.
* for propofol initial target plasma concentration (Cp) is set to 4 micrograms/ml (modified Marsh model)( Base Primea™, Fresenius, France) and then adjusted in steps 0.2 micrograms/ml to maintain the BIS values between 40-55 during surgery.
* for Remifentanil initial Cp is set at induction at 4 ng/ml and then the Cp is maintained between 3-8 ng/mL(increments of 0.5 ng/ml in case of inadequate anesthesia).
* intervention:blood sampling for IL measurement

* include 35 patients with colorectal cancer undergoing surgery
* anesthesia is induced with propofol bolus 1,5-2 mg/kg and remifentanil TCI mode (Minto model) (Base Primea™, Fresenius, France) with an initial Cp 4 ng/ml
* maintenance of anesthesia is achieved with isoflurane 1-1.5 MAC in order to maintain the BIS value between the values of 40-55 and remifentanil TCI with Cp between 3-8 ng/mL (increments of 0.5 ng/ml in case of inadequate anesthesia)
* intervention:blood sampling for IL measurement

Blood sampling to determine interleukins IL6 , IL10 plasma levels are drawn at the following moments:

* T0- before the induction of anesthesia (venous cannula insertion time)
* T1- after induction but before starting surgery

  * In the group I (TIVA -TCI) when the plasma concentration of propofol is 3-3.5 ng/ml
  * In group II (ISOFLURANE) when concentration of isoflurane in exhaled air (Et Isoflurane) is between 0.3-0.5%
* T2, T3- at 2 and 24 hours after surgery

blood sampling for IL measurement

Simona C Margarit, lecturer

Knowing the fact that the anesthetic substances can alter the immune response during the surgery, the purpose of the study is to evaluate the influence of two general anesthetic techniques - inhalation vs. total intravenous anesthesia on the immune response in patient with colorectal surgery for neoplastic disease, evaluated by the plasma level of the interleukins 6 and 10(IL6, IL10).

Introduction

Several factors are contributing to perioperative immunosuppression such as: surgery itself, general anesthesia. In vivo and in vitro studies have shown that anesthesia itself may alter the immune response either by direct effect on immune cells (such as natural killer and T helper) ) or indirectly by the influence of anesthetic substances on pro (IL-1, IL-6, tumor necrosis factor alpha ) and anti-inflammatory ( IL-4, IL-10) cytokines release.

The study aims to evaluate the influence of two general anesthetic techniques inhalation versus total intravenous anesthesia- target controlled infusion (TIVA-TCI) on the immune response in patient with colorectal surgery for neoplastic disease, evaluated by the plasma level of the interleukins IL6, IL10.

Study group:

- patients admitted to the Surgical Clinic of the Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor, undergoing open surgery for colorectal cancer (right/left colectomy, colorectal resection).

After obtaining written informed consent 70 ASA physical status I-III patients scheduled for colorectal cancer resection are randomly allocated to 2 groups of study by computer randomization:

* group I, TIVA-TCI (n=35 patient) receive total intravenous-target controlled infusion anesthesia with propofol and remifentanil
* group II (ISOFLURANE) (n=35 patients) receive inhalatory anesthesia with isoflurane and remifentanil

Methods:

* Premedication with midazolam 7.5 mg orally 30 min before surgery in all patients.
* On arrival in the operating room a venous cannula is inserted and a blood sample for interleukin measurement is performed. This cannula is designated for fluid administration during anesthesia and for blood sampling for subsequent interleukin measurements. A second cannula is inserted for the administration of anesthetic substances.

In group I (TIVA-TCI):

* anesthesia is induced with a target-controlled infusion (TCI) of propofol with an initial target plasma concentration (Cp) of 4 micrograms/ml (modified Marsh model)( Base Primea™, Fresenius, France), adjusted in steps 0.2 micrograms/ml to maintain the BIS values between 40-55 during surgery.
* propofol infusion stops at the end of surgery before the last 2 stitches.

In group II (ISOFLURANE):

* anesthesia is induced with propofol bolus 1,5-2 mg/kg.
* maintenance of anesthesia is achieved with isoflurane 1-1.5 MAC in order to maintain the BIS value between the values of 40-55.
* isoflurane administration cease before the last 2 stitches.

In both groups:

* remifentanil TCI mode (Minto model) (Base Primea™, Fresenius, France) is used for analgesia, with an initial Cp of remifentanil set at 4 ng/ml at induction, and a Cp between 3-8 ng/mL during maintenance(increments of 0.5 ng/ml) depending on the painful moments of surgery and the patient's analgesic needs assessed by changes in heart rate, blood pressure (more than 20% of the previous value of induction), sweating, tearing.
* remifentanil infusion ceases after suturing the wound.
* muscle relaxation is achieved with atracurium, 0.5-0.6 mg/kg at induction, and further maintained on top up doses as needed. At the end of surgery the residual neuromuscular blockade is reversed with atropine 0.02mg/kg and neostigmine 0.0 5mg/kg.
* the lungs are ventilated with an air/oxygen mixture.

Postoperative analgesia:

* morphine patient controlled analgesia(PCA ) with boluses of 1 mg to 5 min interval to maintain the VAS ˂ 4 on 10-point visual analogue scale (VAS). The first dose of morphine 0.1 mg/kg is administered 40 minutes before completing the surgery.
* in addition to morphine, is given paracetamol intravenous, 1g every 8 hours. The first dose of paracetamol is administered intra-operatively before the end of surgery.

Monitoring:

1. Intraoperative:

   * ASA basic monitoring: continuous monitoring ECG, heart rate (HR), arterial blood pressure (BP), pulse oximetry (SpO2), CO2 concentration in expired gases (Et CO2), concentration of isoflurane in exhaled gases (Et Iso), minimum alveolar concentration (MAC) of isoflurane, and core temperature.
   * depth of anesthesia - bispectral index (BIS) (BIS Vista -Aspect Medical System, USA).

   Systolic, diastolic blood pressure and HR are recorded every minute at induction time and every 5 minutes after endotracheal intubation, until the end of surgery.

   Hypotension (defined as a decrease of mean arterial blood pressure by over 20% of baseline values) is treated with higher rate of infusion solutions and intravenous boluses of ephedrine 5 mg.

   Inadequate anesthesia (hypertension, tachycardia, lacrimation, sweating) is treated by adjusting the remifentanil infusion as previously mentioned.
2. Postoperative:

   * opioid analgesic requirement in the first 24 hours
   * pain score on the visual analog scale (VAS 0-10)in the first 24 hour
   * incidence of postoperative nausea and vomiting episodes requiring the administration of antiemetic drug (metoclopramide 20 mg or ondansetron 4 mg)

Blood sampling to determine interleukins IL6 , IL10 plasma levels are drawn at the following moments:

* T0- before the induction of anesthesia (venous cannula insertion time)
* T1- after induction but before starting surgery:

  * in group I (TIVA -TCI) when the plasma concentration of propofol is 3-3.5 micrograms/ml
  * in group II (ISOFLURANE) when concentration of isoflurane in exhaled air (Et Isoflurane) is between 0.3-0.5%
* T2, T3 - at 2 and 24 hours after surgery

The collected blood samples are centrifuged at 2500 rpm / min for 10 minutes and the resulting plasma is stored at -70 ° C until the interleukins assay is performed.

If intraoperatively is revealed local extension of colorectal cancer (tumor invades adjacent organs) or distant metastasis the patient is excluded from the study.

Data collection is done longitudinally prospective, for each patient the following variable are registered:

* quantitative: - weight, plasmatic or brain concentration of the anesthetics used in TIVA-TCI mode, BIS value, plasmatic concentration of the interleukins on 4 intra- and post-operatory moments, the duration of the surgery and anesthesia, number of episodes of nausea and vomiting, opioid analgesic requirement.
* qualitative: ASA score, sex, post-operatory pain score (VAS) Collected data are introduced in a database using the Excel Office programme.

The statistical analysis will be performed using the SPSS 16.0 software (SPSS Inc Chicago, IL, USA). Quantitative variables will be expressed as mean ± SD, and qualitative variables as absolute and relative frequencies. Given multiple measurements at different time intervals, area under curve (AUC) is calculated for each IL and the results will be compared between groups.A p less 0.05 will be considered significant.

The collected blood samples are centrifuged at 2500 rpm / min for 10 minutes and the resulting plasma is stored at -70 °

Anesthetic Technique on Immune Response in Colorectal Cancer

The Influence of Anesthetic Technique on Interleukin Plasma Level in Colorectal Cancer Surgery - TIVA vs Inhalation Anesthesia

at 15, 30 minutes post surgery 6, 12, 18, 24 hours postoperatively

total dose (mg) of remifentanil administered in TCI mode during surgery

-once the intravenous cannula is inserted

* in group I (TIVA-TCI) when plasma concentration of propofol is 3-3.5 micrograms/ml
* in group II (ISOFLURANE) when concentration of isoflurane in exhaled gases (Et iso) is between 0.3-0.5 %

Iuliu Hatieganu University of Medicine and Pharmacy

senior lecturer, consultant in anesthesia and intensive care

Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia

Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site

colorectal cancer resection

Drazen Servis, M.D., Ph.D.

Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.

The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.

In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.

This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.

For each patient, serum samples will be stored at -80°C for later determining of serum cytokine levels

Cytokine Changes After Colorectal Cancer Resection

Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer

Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.

University Hospital Dubrava

M.D., Ph. D.

Musculoskeletal Diseases

Nervous System Diseases

Rare Diseases

Back Pain

Low Back Pain

Necrosis

Pain

Intervertebral Disc Displacement

Neurologic Manifestations

Chronic Graft Versus Host Disease

Serum levels of pro-inflammatory cytokines were measured using the Enzyme Linked Immuno Sorbent Assay (ELISA) technique in 23 patients with pain due to herniated disk disease (G1) as well as in 10 control healthy subject

Five milliliters of venous blood was drawn in the morning from subjects and immediately centrifuged.

blood collect

Durval C Kraychet

The purpose of this study is to:

* evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease
* measured cytokines levels in chronic low back pain and in healthy subjects.

23 patients with at least three months of back pain due to herniated disk disease were selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³ 5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst imaginable pain).

The exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

Study of Cytokines Serum Levels in Chronic Low Back Pain

Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk

Federal University of Bahia

Federal University of São Paulo

Durval Campos Kraychete

Infections

Hypoxia

Shock, Septic

Shock

Sepsis

Toxemia

Communicable Diseases

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

30 Adult patients (age \> 18years), with severe sepsis or septic shock as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference guidelines at the time of admission to ICU.

Blood samples will be taken at ICU admission, and 24h and 48h after admission, and at time of resolution of sepsis

blood sampling

Blood samples will be taken twice at a 7 day interval

Tobias Merz

Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively investigate changes in mitochondrial function of immune cells in patients with severe sepsis and septic shock. The following main hypotheses will be evaluated:

* Severe sepsis and septic shock leads to increased energy requirements of immune cells and to an increase in mitochondrial enzyme activities and energy production.
* Changes of mitochondrial function in human immune cells are associated with alterations in clinical and laboratory markers of severity of sepsis.
* Prolonged sepsis and unfavourable outcome is associated with down regulation of mitochondrial function.

Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to severe sepsis or septic shock will be included in the study; 30 healthy volunteers serve as controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.

Collected baseline characteristics include patient demographics, diagnosis and severity of illness scores at the time of admission. Daily collected follow up data include clinical and laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of antibiotics, use of steroids and results of microbiological cultures/stains.

Negative identification and isolation of monocytes, B cells and CD4 T cells will be performed daily from ICU admission to discharge using an antibody-antigen mediated immunomagnetic cell isolation procedure that depletes all blood cells except the specific target cells. Mitochondrial function of immune cells will be assessed by measurement of mitochondrial complex activity for complexes I to IV by a standard titration protocol. Additionally, the levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6, IL-10, TNF-α) will be assessed throughout the stay in the ICU. For comparison mitochondrial function of of monocytes, B cells and CD4 T cells and cytokine levels will be measured in a group of 10 healthy volunteers.

Analysis plan: Changes in mitochondrial function of immune cells over time compared to a healthy control group and during the course of severe sepsis and septic shock is the main outcome parameter of this study. Assessed predictors are determined by the severity of the underlying septic condition and include clinical and laboratory evidence for dysfunction of vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.

Background

Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. A systematic review on mitochondrial function assessed as oxygen consumption, state 3 and state 4 respiration, respiratory enzyme activity, or tissue ATP levels and turnover rates showed decreased function especially in sepsis models lasting more than 16h . Depleted levels of reduced glutathione, an important intra-mitochondrial antioxidant, in combination with increased generation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) inhibit oxidative phosphorylation and ATP generation. This acquired intrinsic derangement in cellular energy metabolism contributes to reduced activities of mitochondrial electron transport chain enzyme complexes and impaired ATP biosynthesis and contributes to the organ dysfunction in sepsis.

Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis. Immune cell activation mandates an increase in energy requirements, thus a reduced production of ATP due to impaired mitochondrial function may be a factor in modulating the immune response in sepsis. Alterations in mitochondrial function and energetic failure have been reported in peripheral blood mononuclear cells and seem to be associated with the modulation of the immune response to sepsis. Macrophages incubated with endotoxin/interferon-γ show a decrease in oxygen consumption and inhibition of mitochondrial I complex. Different mechanisms for alteration of mitochondrial function in these cells have been proposed, including increases in NO production and nitration of mitochondrial proteins \[14\], elevation of IL-10 \[15\] or prostaglandin levels. In human neutrophils intact mitochondrial function plays an important role in chemotaxis and phagocytosis, impairment of these mechanisms leads to a decreased defence ability to microbial challenges.

HIF-1α is a transcription factor that acts as a key regulatory factor in the evolution of oxygen homeostasis. Under normoxic conditions HIF-1α is continuously synthesized and degraded after hydroxylation by dioxygenases that utilize oxygen, Fe and α-ketoglutarate as substrates. During hypoxia, the low availability of oxygen limits the reaction; HIF-1α is no longer degraded and rapidly accumulates and triggers the transcription of genes involved in oxygen homeostasis such as glycolytic enzymes, glucose transporters, vascular endothelial growth factor (VEGF) and erythropoietin. Under hypoxic conditions, HIF mediates also a decrease in mRNA levels of the respiratory chain proteins, preparing the cell to produce ATP mainly from glycolysis and not from oxidative phosphorylation, thereby optimizing cell energetics and homeostasis for survival and function during hypoxia.

Recent published reports have linked inflammation and endotoxin stimulation to HIF-1α activation. HIF-1α has been shown to be up-regulated and stabilized in LPS-treated macrophages and monocytes under normoxic conditions. HIF-1α levels were shown to be decreased in macrophages deficient in TLR4 after LPS stimulation, suggesting that LPS stimulation of HIF-1α is mediated by TLR4.

Data on mitochondrial function of human immune cells in severe sepsis is limited and the potential correlation of mitochondrial energy requirements and production and the severity of the patient's condition and outcome are not well established. The immunologic reaction in the context of severe sepsis and septic shock consists of an interdependent, highly complex system that involves different types of immune cells and pro- and anti-inflammatory cytokines involved in a time-dependent process. Simple in-vitro studies assessing mitochondrial function of a single type of immune cells and single cytokines just a one point in time during the course of the septic process might not be an appropriate model to mirror the complex interactions of the immune system. Serial measurements of mitochondrial function of different key-player cells and specific pro- and anti-inflammatory cytokines and apoptosis markers parallel with other clinical and laboratory markers of sepsis may offer a more in-depth evaluation and understanding of this deleterious disease pattern.

Objective

The aim of the project is to comprehensively investigate changes in mitochondrial function and morphology of immune cells in patients with severe sepsis and septic shock. We plan to assess changes in mitochondrial function of monocytes, B cells and CD4+ T cells in correlation to levels of various cytokines and to classic clinical and laboratory parameters of severity of sepsis and outcome.

Methods

A total of 30 patients admitted to the intensive care unit (ICU) of a tertiary care hospital due to severe sepsis or septic shock will be included in the study after obtaining written informed consent of the patient or the patient's next of kin. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.

Controls: 30 healthy volunteers Assessment of mitochondrial function of monocytes/granulocytes will be performed by measurement of mitochondrial complex activity using a standard titration protocol to measure activation of complex I to IV. To measure serum levels of IL-1, IL-6, IL-10 and TNF standard commercial kits will be used.

Serum, isolated B-cells, T-cells, Monocytes

Mitochondrial Function of Immune Cells in Sepsis

Mitochondrial Function of Immune Cells in Severe Sepsis and Septic Shock - a Prospective Observational Cohort Study

Insel Gruppe AG, University Hospital Bern

Heart and Blood Diseases

Coronary Artery Disease

Myocardial Ischemia

Arteriosclerosis

Coronary Disease

Ischemia

Arterial Occlusive Diseases

Vascular Diseases

Heart Diseases

Cell saver intraoperatively for coronary artery bypass grafting using cardiopulmonary bypass

Cell saver

Conventional suction for coronary artery bypass grafting using cardiopulmonary bypass

No cell saver

Sune Damgaard, MD

Daniel A Steinbrüchel, Professor

Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body. This leads in few percent of cases to heart, lung, and kidney disturbances that potentially causes death. White blood cells in contact with the heart and lung machine and external surfaces release mediators partly responsible for this. Blood collected by the suction and the blood remaining in the heart and lung machine after its use, can be cleaned by a cell saver before reinfusion, and this might reduce the inflammatory response.

Introduction

Cardiopulmonary bypass (CPB) during cardiac surgery induces in all patients a systemic inflammatory response syndrome (SIRS) that is more pronounced than for other surgical procedures. Depending on the severity of this, myocardial dysfunction, respiratory failure, renal and neurological dysfunction, coagulation disturbances and impaired liver function might follow. In worst cases this leads to acute respiratory distress syndrome, disseminated intravascular coagulation, multi organ failure, shock and death. The cause is besides the surgical trauma, the passage of the blood through the extra corporal circulation (ECC) and its pumps and oxygenator, hemodilution, hypothermia, heparin and protamine administration, ischemia and reperfusion, and endotoxemia (LPS) as a cause of intestinal ischemia. The ECC is the main cause of immunological activation and leads in severe cases to the so-called post-perfusion syndrome. This is characterised by increased capillary permeability and intercellular fluid, peripheral vasoconstriction, fever, myocardial edema, diffuse cerebral edema and diffuse hemorrhagic diathesis. This syndrome is considered to be a more severe form of SIRS. Even though most patients have no sequelae after CPB, all patients must be considered to be influenced, in varying degree, by SIRS. High levels of pro-inflammatory cytokines (interleukin (IL)-6, IL-8, IL-1a, IL-1b, tumor necrosis factor (TNF) alfa), have generally been associated with adverse events after CPB. Of importance is also LPS from gram-negative intestinal bacteria, translocating to the systemic circulation during ischemia.

Hypothesis

Cleansing of suction blood and the remaining blood in the ECC after termination of CPB, reduces the load of inflammatory cells and mediators in the patients' circulation. This potentially diminishes SIRS with a reduction in postoperative organ dysfunction and morbidity.

Aim

To cleanse suction blood and the remaining blood in the ECC after termination of CPB by means of a cell saver and monitor the influence on inflammatory mediators and the potential clinical benefits.

Outcome measures

Primary: Concentrations of IL-1B, IL-6, IL-8, IL-10, IL-12p70, TNFa, TNF-R1, TNF-R2, PCT and LPS in patient blood: 6, 24 and 72 hours after termination of CPB.

Secondary: Bleeding, need for allogenic blood transfusions and blood products and clinical effect focusing on known complications to cardiac surgery and CPB.

Design

Prospective randomised clinical trial including 40 patients planned for on-pump coronary artery bypass grafting (CABG). n=20 in the trial group (use of cell saver) and n=20 in the control group (no cell saver). No patients receive postoperative autotransfusion of drain blood.

Sample size

Estimation based on comparable studies.

Anaesthesia and surgery

In accordance with current guidelines of the clinic, this includes prophylactic antibiotics (cefuroxime and gentamycin). Cell saver: Medtronic Autolog.

Patient exclusion during the trial

Patients are excluded in cases of autotransfusion of blood not cleansed by the cell saver, for instance in cases of major blood loss.

Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response

Does Cleansing of Suction Blood During Cardiac Surgery With Heart and Lung Machine Reduce the Postoperative Inflammatory Response ?

Danish Heart Foundation

Copenhagen Hospital Corporation

Rigshospitalet, Denmark

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Respiration Disorders

Respiratory Tract Diseases

Platelet Aggregation Inhibitors

Sevoflurane

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

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
Anesthetic Technique on Immune Response in Colorectal Cancer	NCT01902849	Colorectal Neop...	blood sampling ...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
Cytokine Changes After Colorectal Cancer Resection	NCT01244022	Colorectal Canc...	colorectal canc...	20 Years - 90 Years	University Hospital Dubrava
Study of Cytokines Serum Levels in Chronic Low Back Pain	NCT00991042	Interleukines	blood collect	20 Years - 65 Years	Federal University of São Paulo
Mitochondrial Function of Immune Cells in Sepsis	NCT01600989	Shock, Septic	blood sampling blood sampling	18 Years -	Insel Gruppe AG, University Hospital Bern
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark
Mitochondrial Function of Immune Cells in Sepsis	NCT01600989	Shock, Septic	blood sampling blood sampling	18 Years -	Insel Gruppe AG, University Hospital Bern
Study of Cytokines Serum Levels in Chronic Low Back Pain	NCT00991042	Interleukines	blood collect	20 Years - 65 Years	Federal University of São Paulo
Cytokine Changes After Colorectal Cancer Resection	NCT01244022	Colorectal Canc...	colorectal canc...	20 Years - 90 Years	University Hospital Dubrava
Anesthetic Technique on Immune Response in Colorectal Cancer	NCT01902849	Colorectal Neop...	blood sampling ...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
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
Cleansing of Suction Blood in Cardiac Surgery for Reduced Inflammatory Response	NCT00159926	Systemic Inflam... Coronary Arteri...	Cell saver No cell saver	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for interleukins

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