A Prospective, Randomised Double-blind Clinical Study of IV Midazolam vs IV Lorazepam for Sedation in ICU Patients Requiring Mechanical Ventilation

INTRODUCTION: Critically ill patients requiring mechanical ventilation often experience pain, agitation, and psychological stress. Effective sedation is crucial for patient comfort, ventilator synchrony, and reducing metabolic demand. Benzodiazepines such as IV midazolam and IV lorazepam have been commonly used, but the relative efficacy, safety, and cost-effectiveness of these agents remain debated.(1–3) This study evaluates the clinical performance of equipotent doses of IV lorazepam versus IV midazolam for sedation in the ICU, addressing gaps in evidence, particularly in resource-constrained settings. OBJECTIVES: AIM: To compare the efficacy, safety, and cost of IV midazolam and IV lorazepam for ICU sedation. Primary Objective: Assess the percentage of time patients spent within the target sedation depth (RASS -2 to 0). Secondary Objectives: Analyse time to target sedation, infusion adjustments, ventilator-free days, ICU, and hospital stays, and incidence of complications. Cost differences between the drugs were also evaluated. MATERIALS AND METHODS: This randomized, double-blind clinical trial was conducted at a tertiary ICU over 18 months, enrolling 126 adult patients requiring mechanical ventilation and sedation for at least three days. Patients were randomized to receive either IV midazolam or IV lorazepam by continuous infusion. Sedation levels were monitored using the RASS scale, with adjustments made to maintain target sedation. Primary and secondary outcomes were analysed using intention-to-treat and per-protocol approaches. Statistical analysis was performed with SPSS 25.0, with a significance threshold of p < 0.05. RESULTS: Demographic and baseline clinical characteristics were comparable between groups. The percentage of time spent within the target sedation depth was similar (76.49% for lorazepam vs. 75.78% for midazolam; p = 0.84). Secondary outcomes, including time to sedation, infusion adjustments, and ICU/hospital stay, showed no significant differences. Safety profiles were comparable, with similar rates of metabolic acidosis and hypotension. Notably, lorazepam demonstrated a significant cost advantage (₹66.91/day vs. ₹246.63/day; p < 0.001). DISCUSSION/CONCLUSION: This study found no significant difference in the efficacy or safety of IV lorazepam and IV midazolam for ICU sedation. However, lorazepam's lower cost offers an advantage in resource-limited settings. These findings support the use of lorazepam as an effective and economically favourable alternative for ICU sedation. Further multicentre studies could validate these results and explore long-term outcomes.