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CompletedNCT07550751FESSUpdated Apr 24, 2026

Optimal Dosage of Melatonin for Preoperative Sedation in FESS

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

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.

02

Conditions studied

  • Clinical Trial
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
160 participants (actual)

Study arms

  • Other
    A

    placebo

    Drug: Melatonin

  • Other
    B

    Melatonin 3mg

    Drug: Melatonin

  • Other
    C

    Melatonin 5mg

    Drug: Melatonin

  • Other
    D

    Melatonin 10mg

    Drug: Melatonin

Interventions

  • DrugMelatonin

    comparison between placebo and different melatonin doses(3-5-10 mg)

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

06

Study locations

1 site
  • Aswan university hospitals
    Aswān, Egypt
07

Registry details

Key details

Study ID
NCT07550751
Lead sponsor
Aswan University Hospital
Responsible party
Osaid Abdelshakour Elsayed Abdallah (anesthesia, surgical intensive care unit and pain management resident doctor., Aswan University Hospital) — Principal investigator
First posted
Apr 24, 2026
Start date
Aug 1, 2024
Primary completion
Apr 30, 2025
Completion
Oct 1, 2025
Last update
Apr 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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