Clinical TrialPhase 4FESSNCT07550751
Optimal Dosage of Melatonin for Preoperative Sedation in FESS
A Phase 4 study testing Melatonin in people with Clinical Trial, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Melatonin Dosage for Effective Sedation, Hemodynamic Stability and Pain Control in Functional Endoscopic Sinus Surgery (FESS)
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
- Conditions
- Clinical Trial
- Being tested
- Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
comparison between placebo and different melatonin doses(3-5-10 mg)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | placebo Receives: Drug: Melatonin |
| B | Other | Melatonin 3mg Receives: Drug: Melatonin |
| C | Other | Melatonin 5mg Receives: Drug: Melatonin |
| D | Other | Melatonin 10mg Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative sedation using ramsay sedation scale
assess of sedation pre-induction of anesthesia and one hour after recovery
Measured: just before intravenous anesthetic induction and one hour after recovery
Secondary outcomes (5)
perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale
Questionnaire assessment of anxiety
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and perioperative
Postoperative pain assessment using Visual Analogue score of pain
Assessment of the effect of melatonin on postoperative pain management
Measured: 1,2,4and6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Aug 2024
- Primary completion30 Apr 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osaid Abdelshakour Elsayed Abdallah, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550751
- Sponsor's protocol ID
- Asw.Uni. / 965 / 9 / 24
- Acronym
- FESS
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Melatonin Dosage for Effective Sedation, Hemodynamic Stability and Pain Control in Functional Endoscopic Sinus Surgery (FESS)
- ClinicalTrials.gov ID
- NCT07550751
- Acronym / sponsor ID
- FESS / Asw.Uni. / 965 / 9 / 24
- Conditions
- Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the optimal dosage of Melatonin for preoperative sedation in patients undergoing FESS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Melatoninplacebo |
| B | Other | Drug: MelatoninMelatonin 3mg |
| C | Other | Drug: MelatoninMelatonin 5mg |
| D | Other | Drug: MelatoninMelatonin 10mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 ASA 2 patients scheduled for elective FESS under general anesthesia
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonincomparison between placebo and different melatonin doses(3-5-10 mg) | Drug | A, B, C, D |
Primary outcome
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
5 secondary outcomes
perioperative anxiety using The six-item State-Trait Anxiety Inventory (STAI-6) scale
Time frame: Baseline one hour before surgery, just before induction of anaesthesia and one hour after recovery
Measuring heart rate in beat/min
Time frame: Baseline and perioperative
Measuring blood pressure (systolic, diastolic and mean arterial pressure) in mmHg
Time frame: Baseline and perioperative
Measuring oxygen saturation (in percentage) using pulse oximeter
Time frame: Baseline and perioperative
Postoperative pain assessment using Visual Analogue score of pain
Time frame: 1,2,4and6 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin in people with Clinical Trial, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative sedation using ramsay sedation scale (time frame: just before intravenous anesthetic induction and one hour after recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.