The effect of melatonin on delirium prophylaxis
Not Applicable
- Conditions
- Delirium.Delirium, unspecified
- Registration Number
- IRCT2015022421159N1
- Lead Sponsor
- Vice chancellor for research, Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Inclusion Criteria:
1.Adult patients (> 18 years old) with less than 24 hours duration from ICU admission
2.Normal gastrointestinal function (can tolerate tablet dosage form)
Exclusion Criteria
1.GCS= 8
2.Duration of ICU stay less than 5 days
3.Hypersensitivity to melatonin or any ingredient of melatonin tablet or placebo
4.Past medical history of epilepsy or any seizure attack.
5.Severe heart failure (New York Heart Association classification III/IV)
6.Head trauma
7.RASS (The Richmond Agitation-Sedation Scale) = -4 or -5
8.Past medical history of delirium or mood disorder before ICU admission
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of delirium. Timepoint: Daily (from initial of study for 8 days). Method of measurement: CAM-ICU.
- Secondary Outcome Measures
Name Time Method Duration of delirium. Timepoint: Daily (from initial of study for 8 days). Method of measurement: Daily evaluation of delirium by CAM-ICU.