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New monitor may predict heart danger during nose surgery

NCT ID NCT07435870

Knowledge-focused Sponsor: Fayoum 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study tests whether a device called the Analgesia Nociception Index (ANI) can predict and prevent a sudden drop in heart rate (trigeminal cardiac reflex) during nasal septoplasty. 90 adults undergoing nose surgery will be monitored either with standard tools or with the ANI device. The goal is to see if ANI-guided care reduces the risk of this reflex and improves safety during surgery.

What this could mean

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

Active substance
Analgesia Nociception Index (ANI) monitoring device
What this could lead to
If successful, this could give surgeons a tool to predict and prevent dangerous heart rate drops during nasal surgery, making the procedure safer.
What could go wrong
This is a small, early-stage study (90 people) that only tests a monitoring device, not a treatment. It may not prove that ANI monitoring actually prevents complications in routine practice.

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.

Participants

About 90 people

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

Started

Apr 2026

Expected to finish

May 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.

Who is studied

Adult patients scheduled for elective nasal septoplasty under general anesthesia will be enrolled.

Ages

18 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 18-60 years. * American society of anesthesiologist physical status I-II * Indicated for primary septoplasty. Exclusion Criteria: * Known cardiac arrhythmias or conduction disorders. * Use of beta-blockers or antiarrhythmic medications. * Previous nasal surgery and Combined nasal procedures. * Inability to obtain reliable Analgesia Nociception Index readings.

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Conditions

The condition(s) this trial relates to.

otorhinolaryngologic disease

As listed by the trial registrant

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

Ent disease

Contacts and locations

Locations

  • Fayoum univeristy hospital

    Al Fayyum, Faiyum Governorate, 63514, Egypt