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To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | placebo |
|
| B | Other | Melatonin 3mg |
|
| C | Other | Melatonin 5mg |
|
| D | Other | Melatonin 10mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | comparison between placebo and different melatonin doses(3-5-10 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| preoperative sedation using ramsay sedation scale | assess of sedation pre-induction of anesthesia and one hour after recovery | just before intravenous anesthetic induction and one hour after recovery |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale | Questionnaire assessment of anxiety | Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery |
| Measuring heart rate in beat/min |
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Inclusion Criteria:
- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan university hospitals | Aswān | 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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randomized controlled trial
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Effect of preoperative different doses of melatonin on heart rate as a part of hemodynamic stability |
| Baseline and perioperative |
| Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg | Effect of preoperative different doses of melatonin on blood pressure as a part of hemodynamic stability | Baseline and perioperative |
| Measuring oxygen saturation (in percentage) using pulse oximeter | Effect of preoperative different doses of melatonin on oxygen saturation as a part of hemodynamic stability | Baseline and perioperative |
| Postoperative pain assessment using Visual Analogue score of pain | Assessment of the effect of melatonin on postoperative pain management | 1,2,4and6 hours postoperative |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |