A randomized controlled trial: Comparing blood pressure reduction in hyperacute phase of spontaneous intracerebral hemorrhage by continuous nicardipine infusion with or without a preceding nicardipine bolus dose

Abstract

ObjectivesTo 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). DesignDouble-blind randomized controlled trial. SettingOne academic emergency department (ED) in Bangkok, Thailand. ParticipantsAdult patients with spontaneous ICH presented to the ED between June 30, 2022, and July 15, 2023. InterventionsThe 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 outcomesSystolic blood pressure (SBP) within the first hour (being measured every 5 min), neurological deterioration, and infusion dosage at 60 min were assessed. ResultsBasic 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). ConclusionsAdministering 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.