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INSPiRE-ICU Pooled Analysis
NCT06809218Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2022
- Primary completion
- Nov 2024
- Countries
- 1
- Sponsor
- Sedana Medical
- Modality
- Allosteric Modulators
- Drugs
- isoflurane
- Conditions
- sedation
01
Overview
Phase 3, randomised, single-blind trial of isoflurane in sedation (2 arms), sponsored by Sedana Medical. Primary endpoint: Cognitive function. Started Apr 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Isoflurane
Inhaled isoflurane delivered via Sedaconda ACD-S
Propofol
Intravenous propofol infusion
03
Who it enrols
Patients who were enrolled in the parent studies INSPiRE-ICU1 (NCT05312385) or INSPiRE-ICU2 (NCT05327296) and survived to discharge.
04
Endpoints
Primary
Cognitive function
Secondary
Memory panorama from time in the ICU
Physical outcomes and trajectories
Depressive symptoms
Anxiety symptoms
Post-traumatic stress symptoms
Quality of life
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