A Phase 4 interventional study of Melatonin in Clinical Trial, sponsored by Aswan University Hospital. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Aswan University Hospital · Phase 4, Interventional, and Other
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Exclusion Criteria:
placebo
Drug: Melatonin
Melatonin 3mg
Drug: Melatonin
Melatonin 5mg
Drug: Melatonin
Melatonin 10mg
Drug: Melatonin
comparison between placebo and different melatonin doses(3-5-10 mg)
preoperative sedation using ramsay sedation scale
assess of sedation pre-induction of anesthesia and one hour after recovery
Time frame: just before intravenous anesthetic induction and one hour after recovery
perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale
Questionnaire assessment of anxiety
Time frame: Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery
Measuring heart rate in beat/min
Effect of preoperative different doses of melatonin on heart rate as a part of hemodynamic stability
Time frame: 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
Time frame: 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
Time frame: Baseline and perioperative
Postoperative pain assessment using Visual Analogue score of pain
Assessment of the effect of melatonin on postoperative pain management
Time frame: 1,2,4and6 hours postoperative
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Aswan University Hospital