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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
1,476 Previous Clinical Trials
485,140 Total Patients Enrolled
Tumul Chowdhury, MDPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for or have had an awake brain surgery.I am not pregnant and not a child.I have been diagnosed with severe adrenal gland problems.I am scheduled for an elective procedure between July 1, 2022, and December 28, 2023.I am over 18 years old.I am suspected to have a low-grade brain tumor or non-glial brain tumor.I can safely undergo an MRI after surgery.My brain cancer has come back.I am scheduled for a surgery to remove a suspected severe brain tumor.My surgery requires special monitoring that affects anesthesia choice.
Research Study Groups:
This trial has the following groups:- Group 1: Sevoflurane group
- Group 2: Propofol group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open slots in this experiment?
"Clinicaltrials.gov confirms that this research project, which was launched on January 1st 2022, is actively enlisting participants. The details were last updated on August 18th 2023."
Answered by AI
Are there any other research projects that have focused on the effects of Propofol?
"Currently, 64 Propofol group trials are active with 13 at the Phase 3 level. Jinan, Shandong is amongst the 257 locations performing clinical trials for Propofol group."
Answered by AI
What is the cumulative figure of participants in this trial?
"Indeed, the clinical trial is still open for enrollment. According to the data hosted on clinicaltrials.gov, it was originally posted in January 1st 2022 and updated most recently in August 18th 2023. A total of 40 patients are required at a single site."
Answered by AI
What conditions can be addressed with Propofol-based treatments?
"Propofol group is a go-to treatment for sedative therapy, as well as general anesthesia, preoperative or intra-procedural sedation and postoperative pain management."
Answered by AI
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