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

JRCT ID: jRCT1051220015

Registered date:23/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hyperactive delirium
• Date of first enrollment: 13/05/2022
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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-ICU) after 19:00 during the participants stay in the High Dependency Unit, infusion of dexmedetomidine is started at 0.3 to 0.7 microgram/kg/h and is maintained at 0.1 to 0.7 microgram/kg/h to keep the RASS score at between -3 and 0 until 6:00 the next day. A loading dose of less than or equal to 6 micrograms/kg/h for 10 minutes is permitted if the participant shows much agitation such as a RASS score of 3 to 4.

Haloperidol group
Haloperidol; 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 is administered by bolus injection or drip infusion for 30 minutes or by intramuscular injection. If the participant does not achieve a RASS score of less than or equal to 0 within 1 hour from the first administration of haloperidol, haloperidol 2.5 mg is additionally administered by bolus injection or drip infusion for 30 minutes or by intramuscular injection.

Outcome(s)

• Primary Outcome: 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

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
Incidence of delirium in all participants

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ohtsuru Shigeru