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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for an elective procedure between July 1, 2022, and December 28, 2023.
Select...
I am scheduled for a surgery to remove a suspected severe brain tumor.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of recruitment
rate of protocol adherence
retention rate
Secondary outcome measures
Overall survival
Progression free survival

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

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,484 Previous Clinical Trials
489,377 Total Patients Enrolled
Tumul Chowdhury, MDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Propofol group (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04962672 — N/A
Anesthesia Research Study Groups: Sevoflurane group, Propofol group
Anesthesia Clinical Trial 2023: Propofol group Highlights & Side Effects. Trial Name: NCT04962672 — N/A
Propofol group (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04962672 — N/A
~6 spots leftby Dec 2024
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