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The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.
This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin group | Active Comparator | The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. |
|
| Control group | Placebo Comparator | The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium occurrence | Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium. | Perioperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Sedation | Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation | Perioperative. |
| Intensity of pain | Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abd-Elazeem A Elbakry, MD | Menoufia University | Principal Investigator |
| Hazem E Elsersy, MD | Menoufia University | Principal Investigator |
| Islam M El-Desoky, MD | Menoufia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Cairo | Shebin El-kom | 32511 | Egypt |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group. |
|
| Perioperative |
| Mean arterial blood pressure | mmHg | Perioperative |
| Heart rate | beats/minute | Perioperative |
| Hypotension | Number of patients with hypotension | Perioperative |
| Hypoxia | Number of patients with hypoxia | Perioperative |
| Blood transfusion needs | Number of patients needed blood transfusion | Perioperative |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |