What is the mechanism of action of this treatment?

The most common treatments for general anesthesia include Total Intravenous Anesthesia (TIVA) using Propofol and Volatile Agents such as sevoflurane, isoflurane, and desflurane. Propofol works by enhancing the activity of gamma-aminobutyric acid (GABA) receptors, the major inhibitory neurotransmitters in the brain, leading to sedation and hypnosis. Volatile agents induce central nervous system depression by enhancing GABA activity and affecting other ion channels, which decreases neuronal excitability. Understanding these mechanisms is crucial for tailoring anesthesia plans to individual patient needs, optimizing safety, and improving recovery outcomes.

What side effects are associated with this type of intervention?

Total Intravenous Anesthesia (TIVA) using Propofol can cause side effects such as hypotension, bradycardia, pain on injection, and, with prolonged use, propofol infusion syndrome. Volatile agents like sevoflurane, isoflurane, and desflurane may lead to postoperative nausea and vomiting, malignant hyperthermia, respiratory depression, and cardiovascular instability. Both methods have distinct risk profiles and should be selected based on individual patient needs and surgical context.

What prior FDA approvals exist?

Propofol, an intravenous anesthetic that enhances GABA activity, is FDA-approved for the induction and maintenance of general anesthesia. Similarly, volatile agents like sevoflurane, isoflurane, and desflurane, which cause central nervous system depression, are also FDA-approved for the same purposes. Both types of anesthetics are widely used and have well-established efficacy and safety profiles.

What other types of research exist?

Promising novel alternatives to Total Intravenous Anesthesia using Propofol and Volatile Agents for general anesthesia include the use of intravenous lidocaine, which has shown efficacy in reducing postoperative pain and opioid consumption, and noninvasive neuromodulation techniques, which have demonstrated potential in reducing tremor and improving patient outcomes during surgery. Additionally, the use of gabapentinoids like pregabalin and gabapentin for perioperative pain management is being explored for their potential benefits in reducing postoperative pain and enhancing recovery.

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Corticosteroid

Anesthesia Types for Cancer Surgery (GA-CARES Trial)

Phase 4

Waitlist Available

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

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

Must have

Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures: Lobectomy or pneumonectomy, Esophagectomy, Radical (total) cystectomy, Pancreatectomy, Partial hepatectomy, Hyperthermic intraperitoneal chemotherapy (HIPEC), Gastrectomy (subtotal or total), Cholecystectomy or bile duct resection

Be older than 18 years old

Must not have

Age less than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year minimum

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing two ways to keep patients asleep during cancer surgery: one using an IV drug called propofol and the other using inhaled gases. It aims to see which method is better at reducing the risk of death from any cause. Propofol is a widely used intravenous anesthetic known for its potential effects on cancer outcomes.

Who is the study for?

The GA-CARES trial is for adult cancer patients undergoing specific surgeries like lung, esophagus, bladder, pancreas removal or certain chemo procedures. It's not for those under 18, with a very short life expectancy, severe health issues (ASA Class 5), egg/soy allergies, or sensitivity to anesthesia.

What is being tested?

This study compares two ways of keeping people asleep during cancer surgery: using propofol through an IV or inhaling agents like sevoflurane. The goal is to see which method affects survival rates after surgery.

What are the potential side effects?

Propofol may cause low blood pressure, pain at the injection site and can lead to a rare but serious condition called Propofol Infusion Syndrome. Inhaled agents might lower blood pressure and heart rate and could cause nausea or vomiting after waking up.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for a major cancer surgery, such as lung, esophagus, bladder, pancreas, liver, stomach removal or specific chemotherapy.

Exclusion Criteria

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

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year minimum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year minimum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year minimum for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

All-cause mortality

Secondary study objectives

Recurrence free survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Volatile agentExperimental Treatment1 Intervention

Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Group II: Propofol infusionExperimental Treatment1 Intervention

Maintenance of general anesthesia with propofol infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propofol

2017

Completed Phase 4

~1520

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for general anesthesia include Total Intravenous Anesthesia (TIVA) using Propofol and Volatile Agents such as sevoflurane, isoflurane, and desflurane. Propofol works by enhancing the activity of gamma-aminobutyric acid (GABA) receptors, the major inhibitory neurotransmitters in the brain, leading to sedation and hypnosis. Volatile agents induce central nervous system depression by enhancing GABA activity and affecting other ion channels, which decreases neuronal excitability. Understanding these mechanisms is crucial for tailoring anesthesia plans to individual patient needs, optimizing safety, and improving recovery outcomes.

Sevoflurane and propofol increase 11C-flumazenil binding to gamma-aminobutyric acidA receptors in humans.