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Background: Delirium is common in critically ill patients. Haloperidol has long been used for the treatment of delirium. Dexmedetomidine has recently been used to treat delirium among intubated critically ill patients. However, the efficacy of dexmedetomidine for delirium in non-intubated critically ill patients remains unknown. We hypothesize that dexmedetomidine is superior to haloperidol for sedation of patients with hyperactive delirium, and would reduce the prevalence of delirium among non-intubated patients after administration. We will conduct a randomized controlled trial to compare dexmedetomidine and haloperidol for the treatment of nocturnal hyperactive delirium in non-intubated patients in high dependency units (HDUs)., Methods: This is an open-label, parallel-group, randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for nocturnal hyperactive delirium in non-intubated patients at two HDUs of a tertiary hospital. We will recruit consecutive non-intubated patients who are admitted to the HDU from the emergency room, and allocate them in a 1:1 ratio to the dexmedetomidine or haloperidol group in advance. The allocated investigational drug will be administered only when participants develop hyperactive delirium (Richmond Agitation-Sedation Scale [RASS] score ≥1 and a positive score on the Confusion Assessment Method for the ICU between 19:00 and 6:00 the next day) during the night at an HDU. Dexmedetomidine is administered continuously, while haloperidol is administered intermittently. The primary outcome is the proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2h after the administration of the investigational drug. Secondary outcomes include the sedation level and prevalence of delirium on the day following the administration of the investigational drugs, and safety. We plan to enroll 100 participants who develop nocturnal hyperactive delirium and receive one of the two investigational drugs., Discussion: This is the first randomized controlled trial to compare the efficacy and safety of dexmedetomidine and haloperidol for sedation of non-intubated critically ill patients with hyperactive delirium in HDUs. The results of this study may confirm whether dexmedetomidine could be another option to sedate patients with hyperactive delirium., Trial Registration: Japan Registry of Clinical Trials, jRCT1051220015, registered on 21 April 2022., (© 2023. The Author(s).)

Purpose: Few studies are available on withdrawal seizures about dexmedetomidine (DEX). Thus, we retrospectively evaluated the incidence of withdrawal seizures after discontinuation of DEX and examined potential risk factors in infants after cardiovascular surgery., Methods: The medical records of 142 infants who had undergone cardiovascular surgery between April 2010 and November 2013 were examined. Clinical characteristics and usage of DEX were analyzed. DEX withdrawal seizures were evaluated using Withdrawal Assessment Tool - version 1 (WAT-1). All the patients and controls were categorized according to DEX discontinuation strategy, which was either gradual or abrupt., Results: Nine patients (6.3%) developed generalized clonic or generalized tonic-clonic seizures accompanied by preceding fever of >38°C approximately four to eight hours following the discontinuation of DEX, and were clinically diagnosed as DEX withdrawal seizures with a median WAT-1 score of 3. Clinical characteristics and operative data were similar, but median cumulative dose and maximum temperature after discontinuation of DEX were significantly higher in infants with withdrawal seizures than in those without (P=0.007 and P<0.001, respectively). Eight of the 9 patients with withdrawal seizures (88.9%) and 20 of the 133 patients (15.0%) with no withdrawal seizures had discontinued DEX abruptly (P<0.001). Cumulative dose and abrupt discontinuation of DEX were significantly associated with DEX withdrawal seizures in infants after cardiovascular surgery (R=0.619, P=0.004)., Conclusions: Physicians should be aware that infants who received DEX after cardiovascular surgery had potential to cause withdrawal seizures accompanied by preceding pyrexia after discontinuation of DEX. Higher cumulative dose and abrupt discontinuation of DEX appears to increase the risk for these withdrawal seizures., (Copyright © 2016 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.)