About this trial
This study aims to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65-90 years
Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours
Disqualifiers
Blind, deafness or the inability to speak mandarin
Allergy to dexmedetomidine.
Renal and liver failure requiring dialysis or Child-Pugh score > 5
Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
Trial design
Parallel
Treatments tested in this trial
Dexmedetomidine
DrugIntranasal dexmedetomidine (100 µg total: 4 sprays, 25 µg/spray; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).
Placebo
DrugIntranasal water for injection (4 sprays, identical volume as nasal dexmedetomidine; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
Confusion Assessment Method
Secondary outcomes
Delirium severity
Confusion Assessment Method Score
Physical activity
Fitbit Flex2 tracker
Sleep quality
Fitbit Flex2 tracker and Athens Insomnia Scale
Anxiety
Hamilton Anxiety Scale
Other outcomes
Optional intranasal administration on the night of surgery
Optional intranasal administration of the same spray (patient decides dose: 0, 2 sprays, or 4 sprays)
Length of Hospital Stay
Medical Record Review
Cognitive function
Abbreviated Mental Test Score
Locations
Sponsors and contacts
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