NONSEDA
Trial question
Is nonsedation superior to light sedation in mechanically ventilated patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 700
700 patients (273 female, 427 male).
Inclusion criteria: patients undergoing mechanical ventilation in the ICU.
Key exclusion criteria: severe head trauma, therapeutic hypothermia, status epilepticus, sedation anticipated to be necessary for oxygenation.
Interventions
N=349 no sedation (no regular sedatives).
N=351 light sedation (target RASS -2 to -3).
Primary outcome
Death at 90 days
42.4%
37%
42.4 %
31.8 %
21.2 %
10.6 %
0.0 %
No
sedation
Light
sedation
No significant
difference ↔
No significant difference in death at 90 days (42.4% vs. 37%; ARD 5.4, 95% CI -2.2 to 12.2).
Secondary outcomes
No significant difference in days alive at 90 days (13 days vs. 12 days; ARD 1, 95% CI -2 to 5).
Borderline significant increase in coma and delirium-free days (27 days vs. 26 days; ARD 1, 95% CI 0 to 2).
No significant difference in ventilator-free days (20 days vs. 19 days; ARD 1, 95% CI -3 to 3).
Safety outcomes
No significant differences in accidental extubation leading to intubation within 1 hour (1.1% vs. 0.3%, p=0.20).
Conclusion
In patients undergoing mechanical ventilation in the ICU, no sedation was not superior to light sedation with respect to death at 90 days.
Reference
Hanne T Olsen, Helene K Nedergaard, Thomas Strøm et al. Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients. N Engl J Med. 2020 Mar 19;382(12):1103-1111.
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