Isoflurane for Sedation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sedation
Isoflurane - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if a new way to give anesthesia is as good as the standard way. The new way is inhaling isoflurane through a machine, and the standard way is through an IV.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Until 3 months after randomization

60 minutes after EOT
Key Secondary: Compare the cognitive recovery after EOT
Day 30
Other secondary: To compare the safety profile of isoflurane vs propofol
During study treatment
Other secondary: Compare time from sedation termination to extubation
During study treatment up to 48 (±6) hours
Key Secondary: Compare the spontaneous breathing effort
Key Secondary: Compare the use of opioids
Other secondary: To assess Sedaconda ACD-S device deficiencies in patients receiving isoflurane
Other secondary: To compare the use of restraints in patients receiving isoflurane vs propofol
Percentage of time adequate sedation depth
Day 7
Other secondary: Compare delirium and coma free days until 7 days after EOT
Day 30
Other secondary: Compare days alive and free of mechanical ventilation through Study Day 30
Other secondary: Compare days alive and free of the ICU
Hour 4
Key Secondary: Compare the wake up time
Month 3
Other secondary: Compare mortality at 3 months after randomization
Day 30
Other secondary: Compare mortality at 30 days after randomization
Month 6
Other secondary: Compare mortality at 6 months after randomization

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Propofol
1 of 2
Isoflurane
1 of 2

Active Control

Experimental Treatment

235 Total Participants · 2 Treatment Groups

Primary Treatment: Isoflurane · No Placebo Group · Phase 3

Isoflurane
Drug
Experimental Group · 1 Intervention: Isoflurane · Intervention Types: Drug
Propofol
Drug
ActiveComparator Group · 1 Intervention: Propofol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoflurane
2010
Completed Phase 4
~53900

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until 3 months after randomization

Who is running the clinical trial?

Sedana MedicalLead Sponsor
2 Previous Clinical Trials
395 Total Patients Enrolled
2 Trials studying Sedation
395 Patients Enrolled for Sedation
Jeremy Beitler, M.D.Principal InvestigatorColumbia University

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving continuous sedation due to clinical need for sedation to RASS <0.
You are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References