Respiratory Trials·org

Sedation, analgesia & delirium · Choice of sedative

SPICE III randomised trial

Early Sedation with Dexmedetomidine in Critically Ill Patients

SPICE III trial design and results
Design International multicentre randomised controlled trial
Treatment Early dexmedetomidine as the primary sedative
Control Usual care sedation
Population 3904 analysed patients undergoing mechanical ventilation, randomised a median 4.6 hours after eligibility
Follow-up 90 days
Primary endpoint All-cause mortality at 90 days
Result Death at 90 days occurred in 566 of 1948 (29.1%) in the dexmedetomidine group, similar to usual care. Patients receiving dexmedetomidine required supplemental sedatives to achieve the prescribed sedation level.
Secondary endpoints Ventilator-free days, delirium-free days, coma-free days, adverse events

Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that in the usual-care group and required supplemental sedatives to achieve the prescribed level of sedation.

The trial authors, in the published abstract

How it has aged

The largest sedation trial ever run, and decisively neutral. Together with MENDS2 and A2B, the modern position is that sedative choice matters far less than sedation depth — the lesson SLEAP taught from a different direction.

Publications

Early Sedation with Dexmedetomidine in Critically Ill Patients

Shehabi Y, Howe BD, Bellomo R, et al. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med 2019 Jun 27;380(26):2506-2517.

  • No difference in 90-day mortality
  • Supplemental sedatives frequently required alongside dexmedetomidine