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preoperative melatonin, pregabalin or both will be given to all patients preoperative
On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Sedation score (ramsay sedation score)(10) will be recorded on arrival to OR An 18-gauge cannula will be inserted in a peripheral vein and a warmed (37°C) lactated Ringer solution infusion was started. Ondansetron 4 mg will be administered intravenously as a prophylaxis against nausea and vomiting. Thereafter the patient will be supported in the sitting position. Intrathecal anaesthetic (room temperature hyperbaric bupivacaine 0.5% (20 mg) + fentanyl 25 μg (0.5 mL) will be given under complete aseptic technique . The patient was returned to the supine position for 15 min then to lateral position with operative side up.
HR and blood pressure will be measured every 2.5 minutes intraoperatively, however, the values will be recorded in the anesthesia chart only every five minutes for 2 hours then every 15 minutes for 3 hours. Durations will be calculated considering the time of spinal injection as time zero.
Hypotension (SAP<100 mmHg or <80% of the baseline measured before spinal anaesthesia) will be treated by ephedrine 6 mg, to be repeated if inadequate response within 2 minutes. If bradycardia (HR≤60 bpm) developed, atropine (0.6 mg) will be given to restore adequate HR (≥60 bpm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| melatonin | Active Comparator | 26 patients will receive melatonin 10 mg |
|
| pregabalin | Active Comparator | 26 patients will receive pregabalin 150 mg |
|
| melatonin and pregabalin | Active Comparator | 26 patients will receive melatonin 5 mg plus pregabalin 75 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS | change of VAS of the patient on a scale from the night before surgery | on arrival to operating room then every 6 hours untill 48 hours |
| Ramsey Sedation scale | change of sedation of the patient on a scale from the night before surgery | on arrival to operating room then every 6 hours untill 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, University Hospitals | Shibīn al Kawm | Menoufia | 32511 | Egypt |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D000069583 | Pregabalin |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Pregabalin | Drug | In the night before surgery, 90 minutes before administering the intrathecal anesthesia and 12 hr after surgery |
|
| Ondansetron 4 MG | Drug | before spinal anaesthesia |
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D006575 | Heterocyclic Compounds, 3-Ring |