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.
Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Aug 2024 to primary completion in Apr 2025, 8 months.
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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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Studies of the drug tested here: Melatonin
Aswan University Hospital