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A pill before surgery may steady the heart and cut bleeding during sinus operations

NCT ID NCT07797946

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests two dose schedules of ivabradine, a drug that slows the heart rate, in 60 adults having endoscopic sinus surgery under general anesthesia. Participants receive either a lower dose, a higher dose, or a placebo pill the night before and the morning of surgery. Researchers measure heart rate and blood pressure at set times during the operation to see which approach keeps them most stable and whether it reduces bleeding.

What this could mean

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

Active substance
Ivabradine, a heart-rate-lowering medication, given as two different oral dose regimens before surgery, compared with placebo.
What this could lead to
If it works, this could point to a simple pre-surgery pill that makes sinus surgery safer and less bloody.
What could go wrong
This is a small, early trial, and the drug may not improve stability or reduce bleeding. Ivabradine can cause side effects like slow heart rate and visual disturbances.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

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

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: * Age between 21 and 60 years of both sexes * ASA physical status I or II * Baseline heart rate ≥ 70 beats per minute in sinus rhythm on preoperative ECG Exclusion Criteria: * Patient refusal or inability to provide informed consent * Baseline heart rate \<70 beats per minute or any degree of heart block on preoperative ECG * Current use of beta blockers, calcium channel blockers, digoxin, or any antiarrhythmic agent * Severe hepatic impairment (Child-Pugh class C) or renal impairment (eGFR\<30 ml/min) * Pregnancy or breastfeeding

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Hemodynamic instability

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