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Melatonin may calm nerves before sinus surgery – study finds optimal dose

NCT ID NCT07550751

Symptom relief Sponsor: Aswan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different doses of melatonin (3, 5, and 10 mg) compared to a placebo in 160 adults undergoing sinus surgery. The goal was to see which dose best reduces anxiety and pain while keeping heart rate and blood pressure stable. Results could help doctors choose the right melatonin dose for a smoother surgical experience.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If successful, this could identify the best melatonin dose to reduce anxiety and improve comfort before sinus surgery.
What could go wrong
This is a small, completed Phase 4 trial. Melatonin is generally safe, but its effectiveness for sedation may vary and may not replace standard sedatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

160 people

The number who actually took part.

Started

Aug 2024

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical trial

Contacts and locations

Locations

  • Aswan university hospitals

    Aswān, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.