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Total Intravenous Anesthesia for Cancer Surgery
Phase 2
Recruiting
Led By Aslam Ejaz, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with pancreatic adenocarcinoma
Adults: >= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying TIVA as an alternative to traditional anesthesia during cancer surgery, which may reduce immunosuppression.
Who is the study for?
This trial is for adults over 18 who have been diagnosed with pancreatic adenocarcinoma and are scheduled for surgery between January 1, 2021, and December 31, 2023. Participants must be able to consent but cannot join if they're prisoners, allergic to Propofol (the study anesthetic), or have a history of malignant hyperthermia from inhaled anesthetics.Check my eligibility
What is being tested?
The TIVACS Study is examining the effects of total intravenous anesthesia (TIVA) after cancer surgery. It's comparing TIVA's benefits like less nausea and quicker bowel function recovery against traditional general anesthesia methods that use volatile agents.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include typical anesthesia risks such as reactions at the injection site, headache, dizziness or muscle pain. Since TIVA uses Propofol, there could also be a risk of low blood pressure or changes in heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pancreatic cancer.
Select...
I am 18 years old or older.
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I had surgery between January 1, 2021, and December 31, 2023.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of anesthetic agent on inflammation and immunosuppression
Secondary outcome measures
Impact of anesthetic choice on short-term anesthetic and surgical outcomes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (surgical resection with TIVA)Experimental Treatment2 Interventions
Patients undergo surgical resection with TIVA.
Group II: Arm II (surgical resection with inhaled volatile anesthetics)Active Control2 Interventions
Patients undergo surgical resection with inhaled volatile anesthetics.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anesthesia Procedure
2020
N/A
~80
Resection
2021
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,087 Total Patients Enrolled
Aslam Ejaz, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with pancreatic cancer.I am 18 years old or older.I had surgery between January 1, 2021, and December 31, 2023.You are allergic to the anesthetic used in the study (intravenous Propofol) or have had a severe reaction to other similar anesthetics in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (surgical resection with TIVA)
- Group 2: Arm II (surgical resection with inhaled volatile anesthetics)
Awards:
This trial has 1 awards, including:- 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.
Has the FDA validated Resection for therapeutic use?
"Although there is evidence of Resection's safety, due to its status as a Phase 2 trial, it can only be scored at 2 in terms of security."
Answered by AI
Are any new participants being considered for this experiment?
"The details posted on clinicaltrials.gov demonstrate that this particular medical trial is no longer accepting participants; it was initially launched January 1st 2023 and last edited November 23rd 2022. Nonetheless, there are 788 other trials currently recruiting individuals for their research."
Answered by AI
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