Dexmedetomidine versus Haloperidol for Sedation of Non-intubated Patients with Hyperactive Delirium during the Night in a High Dependency Unit: an open-label, parallel-group, randomized controlled trial
- Conditions
- Hyperactive delirium
- Registration Number
- JPRN-jRCT1051220015
- Lead Sponsor
- Ohtsuru Shigeru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method