Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302 patients older than 60, undergoing elective vascular surgery will be randomly divided into 2 groups: treatment and control. During the first 5 postoperative days patients will receive sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for the signs of delirium, quality of sleep and severity of pain daily for the first postoperative week. Screening of delirium will be performed by the specially trained research assistant and based on the Confusion Assessment Method and the validated chart review. Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be compared between the groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Other | Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | preoperative assessment up to 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score, using the standard 10-cm visual analog score (0-no pain, 10-worst, unbearable pain) | Preoperative assessment upt to 7 days postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rita Katznelson, MD | Toronto General Hospital, UHn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital, UHN | Toronto | Ontario | M5G 2C4 | Canada |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |