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Can a melatonin pill calm surgery stress better than IV drugs?

NCT ID NCT07568873

Symptom relief Sponsor: Zagazig University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking oral melatonin before sinus surgery could reduce the body's stress response and improve the surgical field, compared to two intravenous drugs (metoprolol and dexmedetomidine) or a placebo. It involved 28 adults undergoing elective functional endoscopic sinus surgery. Researchers measured changes in blood pressure, heart rate, and surgeon satisfaction with the operating conditions.

What this could mean

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

Active substance
Melatonin, Metoprolol, Dexmedetomidine
What this could lead to
If successful, this could point to a simple, low-cost way to reduce stress during surgery and improve conditions for the surgeon.
What could go wrong
This is a small, completed trial with only 28 participants, so results may not apply broadly. The drugs also carry risks like low blood pressure or slow heart rate.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Jan 2024

Finished

Jan 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

21 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Patient acceptance. 2. Age: 21-60 years old. 3. Body mass index (BMI): 18-30 kg/m2. 8 4. Sex: both sexes (male and female). 5. Physical status: American Society of Anesthesiologists (ASA) physical status I and II. 6. Type of operation: elective functioning endoscopic sinus surgery. 7. Duration of surgery: average 2 hours. Exclusion Criteria: 1. Hypertension and those on beta blockers and calcium channel blockers. 2. Diabetes mellitus and bronchial asthma. 3. Cardiac arrhythmias, atrio-ventricular conduction block, pulse less than 60 beats/min systolic blood pressure less than 100 mm hg. 4. Patients with anticipated difficult intubation (Mallampati score III and IV). 5. Psychiatric illness, intake of antipsychotics, sedatives, anxiolytics and antiepileptic drug. 6. The pregnant and lactating females. 7. Allergy to one of the used drugs. 8. Patient with coagulation disorders.

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As listed by the trial registrant

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

Stress response of endotracheal intubation and surgical field clarity in fess

Contacts and locations

Locations

  • Faculty of Medicine, Zagazig Univeristy

    Zagazig, Sharqia Province, 44519, Egypt