NCT07550751CompletedPhase 4
Optimal Melatonin Dosage for Effective Sedation, Hemodynamic Stability and Pain Control in Functional Endoscopic Sinus Surgery (FESS)
Aswan University Hospital1 site in 1 country160 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- preoperative sedation using ramsay sedation scale
Study Overview
Brief Summary
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Exclusion Criteria
- •hypersensitivity or contraindication to the drug
- •Severe psychiatric disorders.
- •Regular use of sedatives or analgesics.
- •Pregnancy or breastfeeding
- •Significant systemic diseases such as severe cardiovascular, hepatic, or renal dysfunction.
Arms & Interventions
D
Other
Melatonin 10mg
Intervention: Melatonin (Drug)
A
Other
placebo
Intervention: Melatonin (Drug)
B
Other
Melatonin 3mg
Intervention: Melatonin (Drug)
C
Other
Melatonin 5mg
Intervention: Melatonin (Drug)
Outcomes
Primary Outcomes
preoperative sedation using ramsay sedation scale
Time Frame: just before intravenous anesthetic induction and one hour after recovery
assess of sedation pre-induction of anesthesia and one hour after recovery
Secondary Outcomes
- perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale(Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery)
- Measuring heart rate in beat/min(Baseline and perioperative)
- Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg(Baseline and perioperative)
- Measuring oxygen saturation (in percentage) using pulse oximeter(Baseline and perioperative)
- Postoperative pain assessment using Visual Analogue score of pain(1,2,4and6 hours postoperative)
Investigators
Osaid Abdelshakour Elsayed Abdallah
anesthesia, surgical intensive care unit and pain management resident doctor.
Aswan University Hospital
Study Sites (1)
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