Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Fentanyl

Anesthetics

Rocuronium

Nitrous Oxide

Propofol

Sevoflurane

Remifentanil

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide.

20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group will received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide.

20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.

Propofol group

20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.

Sevoflurane group

Emad Al Azazi, MD

Tumul Chowdhury, MD

Cancer is a leading cause of death worldwide. It is estimated that approximately 55,000 Canadians are surviving with brain tumors. It is projected that around 3000 persons will be diagnosed with brain and spinal cord tumors, and approximately 75 percent patients will not survive. Out of all brain cancers, high-grade gliomas \[Glioblastoma Multiforme (GBM)\] impose highest morbidity and mortality. Therefore, it is important to explore ways in which Investigators can improve and prolong the lives of patients suffering from brain cancers, particularly high-grade glioma, which is the most common and aggressive primary brain tumor.

So far the Investigators know that the surgery, chemotherapy and radiotherapy are the three corner stones management options for these patients, and majority of the research have been conducted on these three major domains. Therefore, it is imperative to explore the other variables those may impact survival characteristics. One of the integral variables of the brain cancer surgery is anesthesia. Interestingly, the role of anesthetics was explored in some other non-brain solid organ tumor surgeries. It is observed that out of the two main types of anesthesia \[one is through intravenous (propofol) and other one is gaseous (sevoflurane)\], intravenous based anesthesia maintenance regime may delay the cancer progression and prolong the recurrence free period. In addition, two very large retrospective studies with approximately 11,000 and 18,000 patients respectively, showed that as compared to gaseous (volatile anesthetics) based, intravenous (propofol) based anesthesia conferred some protection against cancer progression and was also associated with lesser overall mortality. The exact nature of these protective mechanisms is not known but in animal and other laboratory-based experiments, propofol seems to inhibit cancer formation steps, delays inflammation and provide protection from cancer cell growth. This is a feasibility study for knowing various aspects of workflow; recruitment characteristics of participants and various obstacles in implying anesthesia based protocols so that the Investigators can conduct a well-designed multicenter international randomized study.

In Canada, cancer is the most common cause of death. Among solid organ cancers, brain tumors, depending upon type and grading, impose significant morbidity and mortality. In addition, cancer progression and recurrence is one of the most common complications in management of high-grade gliomas and among all, Glioblastoma Multiforme (GBM) is the most common and aggressive primary brain cancer. Many factors have been demonstrated to affect glioma progression . Some of the most consistently sited variables are age, grade of tumor, tumor size and location, molecular diagnosis, extent of resection, and chemotherapy and radiotherapy.

On the other hand, though, anesthesia remains an integral part of glioma surgeries, and two types of anesthetics (total intravenous agent, such as, propofol and volatile, such as sevoflurane) are commonly used during maintenance phase of general anesthesia (GA) across over all world; their effects on brain cancer progression are not yet investigated extensively. Recent studies have highlighted that there could be an association of anesthesia with cancer progression in other solid organs. Very few researches have been published demonstrating the relationship between type of anesthetic and glioma progression. One study found that exposure of glioblastoma stem cells to volatile agent (isoflurane) increased their migration capacity in vitro and increased their migration distance in vivo in animals. A second study found that exposure of glioma stem cells to sevoflurane increased tumor cell proliferation as well as tumor markers, most notably hypoxia-inducible factors (HIF), which are associated with cancer growth. Finally, a retrospective cohort study published in 2019 compared the progression free survival (PFS) of patients who underwent high-grade glioma surgery using two different types of anesthetics. They found that, for patients with low KPS, anesthesia maintenance with propofol yielded a longer PFS compared to sevoflurane (15). With this background, it seems propofol based anesthesia may limit the progression of brain cancer progression and therefore, the purpose is to evaluate type of anesthetics (propofol versus sevoflurane) as a factor responsible for glioma progression and survival characteristics. As the Investigators are planning for a future phase III study, it is imperative to understand thoroughly the details regarding feasibility, workflow, enrollment and drop out characteristics, reasons of deviation and adherence rates to anesthesia protocols and problems in follow ups. Therefore, this feasibility study is a path to a well-designed larger multicenter randomized study.

Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study

Feasibility outcomes: successful recruitment of trial participants

Feasibility outcomes: successful retention of trial participants

Feasibility outcomes: successful intervention fidelity, identification of barriers to implementation of the intervention, and the feasibility of collecting outcome assessment data.

The following details will be monitored

* date of detection of first progression,
* after surgery radiotherapy (start day after surgery, dose, fractions),
* after surgery chemotherapy (start date after surgery, number of cycles),
* date of the last follow-up

* date of detection of first progression,
* after surgery radiotherapy (start day after surgery, dose, fractions),
* after surgery chemotherapy (start date after surgery, number of cycles),
* date of the last follow-up

University Health Network, Toronto

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The patient who anesthetized by using propofol.

The patient who anesthetized by using propofol

Patient will be anesthetized by using propofol infusion during operation.

propofol group

Patient will be anesthetized by using sevoflurane inhalation during operation.

sevoflurane group

Seong-Hyop Kim, M.D,Ph.D

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

change of percentage of helper T cell (scores range from 0 to 100)

change of percentage of CD39 and CD73 (scores range from 0 to 100)

change of percentage of circulating natural killer cell (scores range from 0 to 100)

Konkuk University Medical Center

Associate Professor

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Patient will be anesthetized by using propofol infusion during operation

Patient will be anesthetized by using sevoflurane inhalation during operation

Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer

change of percentage of natural killer cell (scores range from 0 to 100)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anesthesia Induced Brain Cancer Survival (ABC Survival): A Feasibility Study	NCT04962672	Anesthesia Brain Cancer Survival	Propofol group Sevoflurane gro...	18 Years -	University Health Network, Toronto
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer	NCT02567929	Breast Cancer	propofol group sevoflurane gro...	20 Years -	Konkuk University Medical Center
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer	NCT02567942	Colon Cancer	propofol group sevoflurane gro...	20 Years -	Konkuk University Medical Center
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer	NCT02567929	Breast Cancer	propofol group sevoflurane gro...	20 Years -	Konkuk University Medical Center

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