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The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly

Not Applicable
Conditions
postoperative delirium
Registration Number
JPRN-UMIN000007584
Lead Sponsor
Department of psychiatry, Kobe University Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

Exclusion Criteria

1 Patients with a history of hypersensitivity to this drug. 2 Patients with severe hepatic dysfunction. 3 Patients treated with Fluvoxamine maleate. 4 Patients judged to be unsuitable.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome was the occurrence of delirium as determined by Confusion Assessment Methods-ICU (CAM-ICU) criteria at day 1,2,3,and 7 after operation.
Secondary Outcome Measures
NameTimeMethod
The secondary outcome was the degree of severity of delirium as determined by Method Delirium Assessment Scale (MDAS) criteria if postoperative delirium occurs.
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