MENDS
Trial question
Is dexmedetomidine superior to lorazepam in mechanically ventilated patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 103
103 patients (50 female, 53 male).
Inclusion criteria: mechanically ventilated adult patients in medical and surgical ICU.
Key exclusion criteria: neurological disease; Childs-Pugh class B or C liver disease; moribund state with planned withdrawal of life support; alcohol abuse; active myocardial ischemia, severe dementia; benzodiazepine dependency.
Interventions
N=52 dexmedetomidine (maximum infusion at 1.5 mcg/kg/hr titrated to achieve Richmond Agitation-Sedation Scale score).
N=51 lorazepam (maximum infusion at 10 mg/hr titrated to achieve Richmond Agitation-Sedation Scale score).
Primary outcome
Days alive without delirium or coma
7 days
3 days
7.0 days
5.3 days
3.5 days
1.8 days
0.0 days
Dexmedetomidine
Lorazepam
Significant
increase ▲
Significant increase in days alive without delirium or coma (7 days vs. 3 days; AD 4 days, 95% CI 0.96 to 7.04).
Secondary outcomes
Significant increase in patients with delirium or coma (45% vs. 50%; ARD 5, 95% CI 0.48 to 9.52).
Significant increase in Richmond Agitation-Sedation Scale score within 1 point of sedation goal (80% vs. 67%; AD 13%, 95% CI 0.57 to 25.43).
No significant difference in death at day 28 (17% vs. 27%; RR 0.63, 95% CI -0.29 to 1.55).
Safety outcomes
No significant differences in seizures, self-extubations.
Significant difference in sinus bradycardia (17% vs. 4%).
Conclusion
In mechanically ventilated adult patients in medical and surgical ICU, dexmedetomidine was superior to lorazepam with respect to days alive without delirium or coma.
Reference
Pratik P Pandharipande, Brenda T Pun, Daniel L Herr et al. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007 Dec 12;298(22):2644-53.
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