Sedana Medical (SEDANA) Study Result summary

Study design and endpoints

• Two pivotal INSPIRE-ICU trials in 30 U.S. ICUs enrolled 555 patients, with 470 randomized to compare isoflurane and propofol for ICU sedation.

• The primary endpoint was non-inferiority in percentage of time at target sedation level (RASS scale).

• Key secondary endpoints included opioid reduction, wake-up time, cognitive recovery, and spontaneous breathing, with sequential testing prioritizing opioid reduction.

Key results and findings

• Non-inferiority for isoflurane was confirmed in both studies for the primary endpoint, supported by robust sensitivity analyses.

• Isoflurane showed a 31% and 37% reduction in opioid use, with both studies meeting the key secondary endpoint.

• Over 75% of isoflurane patients woke up within one hour after sedation ended, with no significant difference versus propofol.

• Cognitive recovery at 60 minutes post-sedation and 30-day outcomes were similar between groups.

• Spontaneous breathing was higher with isoflurane in one study, consistent with previous findings.

Additional outcomes and safety

• Trends favored isoflurane for ventilator-free and ICU-free days, with up to 1.7 more ICU-free days, though not statistically significant.

• 30-day, 3-month, and 6-month mortality differences favored isoflurane, but were not statistically significant; a 5% lower 30-day mortality was observed.

• Serious adverse events were overall lower for isoflurane in pooled analysis, with no new safety signals.

• Long-term follow-up showed no clinically important or statistically significant differences between groups.