Hyperactive delirium
Conditions
Interventions
Dexmedetomidine group
Dexmedetomidine
When a participant first attains a Richmond Agitation-Sedation Scale (RASS) score of greater than or equal to 1 and a positive score on the Confusion Assessment Method for the Intensive Care Unit (CAM
When a participant first attains a RASS score of greater than or equal to 1 and a positive score on the CAM-ICU after 19:00 during the participants stay in the High Dependency Unit, haloperidol 2.5 mg
Sponsors
Ohtsuru Shigeru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Non-intubated patients who are urgently admitted to the High Dependency Unit of the Department of Primary Care and Emergency Medicine or the Department of Cardiovascular Medicine at Kyoto University Hospital from the emergency room.
Exclusion criteria
Exclusion criteria: Patients who have received non-invasive ventilation (NIV). Patients with tracheostomy. Patients who have already started to receive dexmedetomidine or haloperidol by bolus injection or drip infusion or intramuscular injection before admission to the High Dependency Unit. Patients with a diagnosis of schizophrenia or mania. Patients with contraindications to haloperidol or dexmedetomidine (e.g., allergy to any of the investigational drugs, prolonged QTc on electrocardiogram) Women who are pregnant or possibly pregnant, and women who are lactating.. Patients who cannot understand Japanese Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve the targeted sedation level (RASS score of between -3 and 0) 2 hours after the start of administration of the investigational drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve a RASS score of between -3 and 0 after the start of administration of the investigational drug Each RASS score at 1, 2, 3, 4, 6 and 8 hours after the start of administration of the investigational drug Proportion of participants with a RASS score of between -3 and 0 at 1, 2, 3, 4, 6, and 8 hours after the start of administration of the investigational drug Duration that the RASS score is between -3 and 0 within the 8-hour period from the start of administration of the investigational drug to 8 hours Proportion of participants with delirium one day after the start of administration of the investigational drug RASS score one day after the start of administration of the investigational drug Number or proportion of delirium-free days during the participants stay in the High Dependency Unit Duration of stay in the High Dependency Unit, and duration of the admission Proportion of participants who require rescue administration of another drug(s) after administration of the investigational drug Safety (oversedation, hypotension, bradycardia, transition to advanced respiratory support such as NIV or invasive mechanical ventilation, and so on) Safety Counterplan (e.g., restraint mittens , physical restraint) Dangerous behavior Contents of nursing care Item B of the severity and medical/nursing care needs assessment Incidence of delirium in all participants Association between delirium subtypes during the first 7 days of hospitalization (no delirium, hyperactive only, hypoactive only, and mixed, defined as the presence of both hyperactive and hypoactive features during the observation period) and their clinical outcomes | — |
Contacts
Public ContactTakuma Minami
Kyoto University Hospital
Outcome results
None listed