"Dexmedetomidine for Sedation in Mechanically Ventilated ICU Patients (SPICE III)". The New England Journal of Medicine. 2019.
Links to original sources: Wiki Journal Post Full Journal Article
Does the use of dexmedetomidine as the primary sedative agent in mechanically ventilated ICU patients reduce mortality rates compared to usual sedation care?
Early use of dexmedetomidine as the primary sedative in mechanically ventilated ICU patients did not result in a lower 90-day mortality compared to other sedatives and was associated with more adverse events.
Dexmedetomidine has been suggested to produce sedation without significant respiratory depression and may decrease the duration of mechanical ventilation and delirium in ICU patients. The SPICE III trial evaluated the effects of using dexmedetomidine as the primary or sole agent for early sedation in 4000 adults in ICU who required mechanical ventilation. The study found no significant difference in 90-day mortality between the dexmedetomidine group and the usual-care group. Dexmedetomidine was frequently supplemented with other sedatives to achieve target sedation levels, and was associated with more adverse events, particularly bradycardia and hypotension.
Not available.
Open-label, randomized, controlled trial. N=4000 mechanically ventilated ICU patients. Intervention: Dexmedetomidine as sole/primary sedative (n=2001). Control: Usual sedation care - propofol, midazolam, or other sedatives (n=1999). Setting: 74 ICUs in eight countries. Enrollment: 2013-2018. Mean follow-up: 90 days. Primary outcome: Death from any cause at 90 days.
Inclusion Criteria: Adults in ICU, requiring mechanical ventilation for more than the next calendar day, receiving sedatives for safety and comfort. Exclusion Criteria: Age <18 years, mechanical ventilation for over 12 hours before enrollment, suspected/confirmed acute primary brain injury. Median age: 63.7 years.
Dexmedetomidine aiming to be the primary sedative, supplemented with propofol, midazolam, or both when required. Usual care consisting of propofol, midazolam, or other sedatives, excluding dexmedetomidine.
Primary Outcome: At 90 days, death from any cause occurred in 29.1% of both dexmedetomidine and usual-care groups (adjusted risk difference, 0.0 percentage points). Secondary Outcomes: No significant differences in 180-day mortality, institution dependency at 180 days, cognitive function, health-related quality of life, days free from coma/delirium, or ventilator-free days at day 28. Additional Findings: Dexmedetomidine group required additional sedatives to maintain target sedation, more target sedation scores achieved in the dexmedetomidine group, deep sedation for clinical reasons frequent in both groups.
The trial was open-label, and the use of supplemental sedation might have affected sedation levels and outcomes.
Supported by the National Health and Medical Research Council of Australia, Health Research Council of New Zealand, National Heart Institute Foundation of Malaysia. Pfizer and Orion Pharma provided dexmedetomidine.
For further information and details related to the SPICE III trial, consult the full text published in the New England Journal of Medicine and ClinicalTrials.gov number NCT01728558.