ABSTRACT
Objectives: To determine whether addition of an intravenous bolus dose before continuous nicardipine infusion would improve blood pressure reduction in the hyperacute phase in patients with spontaneous intracerebral hemorrhage (ICH). Design: Double-blind randomized controlled trial. Setting: One academic emergency department (ED) in Bangkok, Thailand. Participants: Adult patients with spontaneous ICH presented to the ED between June 30, 2022, and July 15, 2023. Interventions: The bolus group (n = 31) received an intravenous bolus dose of nicardipine before nicardipine continuous infusion, whereas the non-bolus group (n = 31) was given a placebo and nicardipine continuous infusion. Main outcomes: Systolic blood pressure (SBP) within the first hour (being measured every 5 min), neurological deterioration, and infusion dosage at 60 min were assessed. Results: Basic characteristic features including the mean baseline SBP were not significantly different between the two groups. At 10 min after treatment initiation, the bolus group had a significant decrease in SBP (32.1 ± 13.6 vs 22.3 ± 18.5 mmHg; p-value = 0.020). Moreover, the target SBP of 180 mmHg could be achieved within 10 min in the bolus group compared with 15 min in the non-bolus group. However, the overall mean SBPs were not significantly different, with 152 ± 12 mmHg in the bolus group compared with 150 ± 15 mmHg in the non-bolus group (p-value = 0.564). None of the patients in both groups had neurological deterioration over the first hour of the treatment. The infusion dosages of nicardipine at 1 h were 6.2 mg/h (5.9, 7.7 mg/h) and 6.8 mg/h (5.9, 8.4 mg/h) in the bolus and non-bolus groups, respectively (p-value = 0.618). Conclusions: Administering a 1-mg bolus dose of nicardipine before continuous nicardipine infusion notably reduces SBP at 10 min. However, the overall SBP does not exhibit a significant decline during the hyperacute phase of spontaneous intracerebral hemorrhage.
