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Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.
Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Patients in this group received nothing for sedation. |
|
| Midazolam group | Active Comparator | 7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively. |
|
| Melatonin group | Experimental | 5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | The patients were assessed using the Memorial Delirium Assessment Scale (MDAS) after the operation at 30, 60, and 90 min. Melatonin was shown to reduce delirium from 41.6% to 16.6% at 60 minutes, and the significant reduction was at 90 minutes (0%) when compared to both groups. Thus, melatonin was found to be successful in decreasing postoperative delirium when administered preoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia | This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates. | 1 week |
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Inclusion Criteria:
1- Patients in good general health. 2. Baseline MDAS <13. 3. No seizure disorder.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Kadhemya Private Hospital | Baghdad | 10047 | Iraq | |||
| Ghazi Al-Hariri Teaching Hospital |
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Patients were divided into three groups at random, with 12 patients in each group, using a double-blinded method.
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It has been done on all the study's contributors and workers.
|
|
| No intervention | Other | No intervention was used. |
|
| Midazolam | Drug | 7.5 mg of Midazolam orally. |
|
| Baghdad |
| 10047 |
| Iraq |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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