Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04962672

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

Led by University Health Network, Toronto · Updated on 2025-01-31

40

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Brain cancer, particularly high-grade gliomas like Glioblastoma Multiforme (GBM), is a significant cause of illness and death worldwide. This research focuses on evaluating how different types of anesthesia used during brain tumor surgery might affect cancer progression and patient survival. While surgery, chemotherapy, and radiotherapy are standard treatments, this study explores the potential influence of anesthetic drugs, an area not extensively studied before. The study is a feasibility trial to understand recruitment and protocol adherence, setting the stage for a larger future study. The study involves 40 patients undergoing elective craniotomy for suspected high-grade glioma. Participants are randomly assigned to one of two groups: one receives total intravenous anesthesia using propofol and remifentanil, while the other receives volatile inhalational anesthesia with sevoflurane and remifentanil. Both groups follow standard fasting and monitoring guidelines, with anesthesia carefully adjusted to maintain specific depth and carbon dioxide levels. No nitrous oxide is used during anesthesia. Participants will be monitored for recruitment and retention rates, adherence to anesthesia protocols, overall survival, and progression-free survival over six months. The study includes regular clinical assessments and postoperative MRI scans to track tumor progression. Researchers will also observe any challenges in following the anesthesia protocols and participant follow-up. This information will help design a more extensive multicenter randomized trial in the future.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient presenting between Jul 1, 2022 and Dec 28, 2023 for elective procedure
  • Males or females of >18 years
  • Patient will be undergoing primary craniotomy (with general anesthesia) for suspected high-grade primary glial brain tumor (WHO grade III and IV)
Not Eligible

You will not qualify if you...

  • Patients of pediatric age group and pregnant patients
  • Patients previously diagnosed with severe adrenal dysfunction (over activity or insufficiency)
  • Suspected low grade (grade I, II), glioma, tumors involving brainstem and optic tract, and as well as non-glial tumors (i.e. suspected brain metastasis)
  • Awake craniotomies
  • Any conditions that preclude postoperative MRI
  • Motor evoked potential monitoring or any other intraoperative condition that renders choice of anesthetics affected
  • Recurrent GBM

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgical procedure day

Participants undergo elective craniotomy for suspected high-grade glioma resection and receive one of two anesthesia types during surgery: either total intravenous anesthesia with propofol or volatile anesthesia with sevoflurane. Standard fasting and monitoring guidelines apply throughout anesthesia.

1 visit (in-person)

Follow-up

Duration - Up to 6 months

Participants are monitored post-surgery for survival, progression-free survival, and adherence to anesthesia protocols over a period of up to 6 months.

Periodic visits up to 6 months

Trial Site Locations

Total: 1 location

1

Toronto Western Hospital/UHN

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

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Research Team

E

Emad Al Azazi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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