What is the mechanism of action of this treatment?

Common treatments for sedation, such as inhaled isoflurane and intravenous propofol, primarily act through central nervous system (CNS) depression. Isoflurane, administered via the Sedaconda ACD-S device, enhances the inhibitory effects of gamma-aminobutyric acid (GABA) on the GABA-A receptors, leading to decreased neuronal excitability and sedation. Similarly, propofol also potentiates GABA-A receptor activity, resulting in rapid onset of sedation. These mechanisms are crucial for sedation patients as they ensure effective and controlled sedation, which is essential for patient comfort and safety during procedures requiring mechanical ventilation or other intensive care interventions.

What side effects are associated with this type of intervention?

Common treatments for sedation, such as inhaled isoflurane and intravenous propofol, are associated with several side effects. Inhaled isoflurane can cause hypotension, respiratory depression, and postoperative nausea and vomiting. Propofol, another widely used sedative, may lead to hypotension, bradycardia, and respiratory depression. Both agents can cause central nervous system depression, leading to drowsiness and impaired cognitive function. Additionally, propofol has been associated with pain on injection and a risk of propofol infusion syndrome with prolonged use.

What prior FDA approvals exist?

The FDA has approved several drugs for sedation, particularly in the context of anesthesia and intensive care. Inhaled anesthetics like isoflurane and sevoflurane are commonly used for their rapid onset and controllable depth of sedation. Isoflurane, in particular, is being studied for its efficacy and safety when delivered via the Sedaconda ACD-S device system for sedation in mechanically ventilated ICU patients. Intravenous sedatives such as propofol are also widely used and approved for sedation due to their quick action and ease of titration. These treatments are essential for managing sedation in various medical procedures and critical care settings.

What other types of research exist?

Promising alternatives to inhaled isoflurane for sedation in mechanically ventilated ICU patients include intravenous dexmedetomidine and propofol. Dexmedetomidine is noted for its ability to reduce postoperative cognitive dysfunction and emergence agitation, while propofol is a well-established sedative with a rapid onset and short duration of action.

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General Anesthetic

Inhaled Isoflurane vs IV Propofol for Sedation (INSPiRE-ICU2 Trial)

Phase 3

Waitlist Available

Led By Jeremy Beitler, M.D.

Research Sponsored by Sedana Medical

Eligibility Criteria Checklist

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

Must have

Receipt of continuous sedation due to clinical need for sedation to RASS <0

Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU

Must not have

Contraindication to propofol or isoflurane

History of ventricular tachycardia/Long QT Syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of study treatment, safety lab from baseline up to 48hrs post treatment, aes from start study treatment up to day 30

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether inhaling a sedative gas called isoflurane through a special device is as safe and effective as the usual methods for adults in the ICU who need help breathing with a machine. Isoflurane has shown better control of intensive care sedation and seems to be a useful alternative.

Who is the study for?

Adults over 18 who need mechanical ventilation and sedation in the ICU for more than 12 hours can join. Excluded are those with allergies to isoflurane or propofol, certain severe neurological or muscular conditions, extreme hemodynamic instability, a history of malignant hyperthermia (MH), ventricular tachycardia/Long QT Syndrome, or on specific other treatments.

What is being tested?

The trial compares two sedation methods for ICU patients on ventilators: inhaling isoflurane using Sedaconda ACD-S versus receiving propofol intravenously. It aims to determine which method is safer and more effective.

What are the potential side effects?

Isoflurane may cause respiratory issues like coughing or wheezing, while propofol can lead to low blood pressure, pain at the injection site, and in rare cases, Propofol Infusion Syndrome with heart failure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am on constant sedation due to my medical condition.

Select...

I am expected to need a breathing machine and sedation in the ICU for more than 12 hours.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I am allergic or cannot take propofol or isoflurane.

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I have a history of irregular heartbeats or Long QT Syndrome.

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I am currently pregnant or breastfeeding.

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I will need a muscle relaxant treatment for more than 4 hours.

Select...

I or someone in my family has a history of malignant hyperthermia.

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I need IV medication for seizures or withdrawal symptoms.

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I have a condition like ALS that affects my ability to breathe on my own.

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I require advanced support for my breathing at screening.

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I need strong medication to keep my blood pressure stable.

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I need a machine to help keep my airways moist while I breathe.

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I was able to participate in studies before my ICU admission.

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I am receiving care focused on comfort, not curing my illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until 3 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until 3 months after randomization

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

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of time adequate sedation depth

Secondary study objectives

Key Secondary: Compare the cognitive recovery after EOT

Key Secondary: Compare the spontaneous breathing effort

Key Secondary: Compare the use of opioids

+11 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IsofluraneExperimental Treatment1 Intervention

Inhaled isoflurane administered via Sedaconda ACD-S

Group II: PropofolActive Control1 Intervention

Propofol administered as intravenous infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isoflurane

2010

Completed Phase 4

~53870

0 / 15Eligibility 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

Common treatments for sedation, such as inhaled isoflurane and intravenous propofol, primarily act through central nervous system (CNS) depression. Isoflurane, administered via the Sedaconda ACD-S device, enhances the inhibitory effects of gamma-aminobutyric acid (GABA) on the GABA-A receptors, leading to decreased neuronal excitability and sedation. Similarly, propofol also potentiates GABA-A receptor activity, resulting in rapid onset of sedation. These mechanisms are crucial for sedation patients as they ensure effective and controlled sedation, which is essential for patient comfort and safety during procedures requiring mechanical ventilation or other intensive care interventions.