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 a risk of propofol infusion syndrome, a rare but serious condition characterized by metabolic acidosis, rhabdomyolysis, and cardiac failure.

What prior FDA approvals exist?

The FDA has approved several drugs for sedation, particularly in ICU settings. Propofol, a widely used intravenous sedative, is commonly employed for its rapid onset and short duration of action. Dexmedetomidine, another FDA-approved sedative, is known for its ability to provide sedation without significant respiratory depression. Inhaled anesthetics like isoflurane have also been used, though typically in operating rooms rather than ICU settings. The Sedaconda ACD-S device system represents a novel approach to delivering inhaled isoflurane for sedation in mechanically ventilated patients, potentially offering an alternative to traditional intravenous sedatives.

What other types of research exist?

Promising alternatives to inhaled isoflurane for sedation in ICU patients include dexmedetomidine and propofol. Dexmedetomidine has been shown to reduce emergence agitation and postoperative delirium in thoracic surgery patients. Propofol remains a widely used intravenous sedative with a well-established safety profile. Both agents offer effective sedation and have been validated in clinical settings.

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Inhaled Anesthetic

Inhaled Isoflurane vs. IV Propofol for ICU Sedation (INSPiRE-ICU1 Trial)

Q: What is the mechanism of action of this treatment?

Common sedation treatments, such as inhaled isoflurane and intravenous propofol, primarily work by enhancing the activity of the inhibitory neurotransmitter GABA in the central nervous system, leading to CNS depression and sedation. Isoflurane, administered via the Sedaconda ACD-S device, and propofol both reduce excitatory neurotransmitter activity, which helps achieve the desired sedative effect. This understanding is essential for optimizing sedation protocols, ensuring patient safety, and improving outcomes in mechanically ventilated patients in ICU settings.

Phase 3

Waitlist Available

Led By Kimberly Rengel, 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

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

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

Must not have

Contraindication to propofol or isoflurane

Comfort care only (end of life care)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 3 months after randomization

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 for more than 12 hours in the ICU can join. They must require a specific level of sedation (RASS <0). Excluded are those with severe neurological issues, life-threatening conditions, allergies to isoflurane or propofol, certain heart problems, pregnant or breastfeeding women, and patients on other conflicting studies.

What is being tested?

The trial compares two types of sedatives: inhaled isoflurane using Sedaconda ACD-S versus intravenous propofol. It aims to determine which one is safer and more effective for keeping ICU patients under sedation while they're on a ventilator.

What are the potential side effects?

Isoflurane may cause coughing, nausea, vomiting or confusion; Propofol can lead to low blood pressure, pain at injection site or propofol infusion syndrome—a rare but serious condition affecting the heart and lungs.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am on constant sedation due to my medical condition.

Select...

I am on constant sedation due to my medical condition.

Select...

I expect 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.

Select...

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

Select...

I am not pregnant or breastfeeding.

Select...

I was sedated for more than 72 hours for a breathing machine before starting the study.

Select...

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

Select...

I expect to need a muscle relaxant infusion for more than 4 hours.

Select...

I need strong medication to keep my blood pressure stable.

Select...

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

Select...

I need IV medication for seizures or withdrawal symptoms.

Select...

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

Select...

I require advanced breathing support.

Select...

I was unable to participate in studies due to a severe neurological condition before ICU admission.

Select...

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

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 / 18Eligibility 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 sedation treatments, such as inhaled isoflurane and intravenous propofol, primarily work by enhancing the activity of the inhibitory neurotransmitter GABA in the central nervous system, leading to CNS depression and sedation. Isoflurane, administered via the Sedaconda ACD-S device, and propofol both reduce excitatory neurotransmitter activity, which helps achieve the desired sedative effect. This understanding is essential for optimizing sedation protocols, ensuring patient safety, and improving outcomes in mechanically ventilated patients in ICU settings.