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Anesthesia Type for Brain Cancer Survival

N/A

Recruiting

Led By Tumul Chowdhury, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient presenting between Jul 1, 2022 and Dec 28, 2023 for elective procedure

Patient will be undergoing primary craniotomy (with general anesthesia) for suspected high-grade primary glial brain tumor (WHO grade III and IV)

Must not have

Awake craniotomies

Patients of pediatric age group and pregnant patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is researching if using a different type of anesthesia during cancer surgery could improve patient survival.

Who is the study for?

This trial is for adults over 18 years old who are scheduled for their first surgery to remove a high-grade brain tumor using general anesthesia. It's not open to children, pregnant women, those with recurrent GBM, severe adrenal problems, low-grade tumors or conditions that prevent post-op MRI.

What is being tested?

The study compares two types of anesthesia in brain cancer surgery: Propofol (intravenous) and Sevoflurane (gaseous). The goal is to see if one can better prolong life by delaying cancer progression based on previous findings suggesting Propofol might be more protective.

What are the potential side effects?

While the side effects aren't detailed here, generally speaking, anesthetics like Propofol and Sevoflurane can cause nausea, vomiting, drowsiness after waking up from surgery and sometimes confusion or memory issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for an elective procedure between July 1, 2022, and December 28, 2023.

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I am scheduled for a surgery to remove a suspected severe brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for or have had an awake brain surgery.

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I am not pregnant and not a child.

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I have been diagnosed with severe adrenal gland problems.

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I am suspected to have a low-grade brain tumor or non-glial brain tumor.

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I can safely undergo an MRI after surgery.

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My brain cancer has come back.

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My surgery requires special monitoring that affects anesthesia choice.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of recruitment

rate of protocol adherence

retention rate

Secondary study objectives

Overall survival

Progression free survival

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Propofol groupExperimental Treatment1 Intervention

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.

Group II: Sevoflurane groupActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propofol

FDA approved

0 / 9Eligibility criteria met