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Could a nasal spray prevent Post-Surgery confusion in seniors?

NCT ID NCT07532577

Prevention Sponsor: Radboud University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This pilot study tests whether giving insulin as a nasal spray can prevent delirium (sudden confusion) in adults aged 65 and older after complex heart surgery. About 30 participants will receive either the insulin spray or a placebo before and after surgery. The goal is to see if the approach is practical, safe, and possibly effective at reducing delirium severity and duration.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

30 people

The number who actually took part.

Started

Apr 2026

Finished

Jul 2026

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

65 years and older

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. Age ≥65 years 2. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG 3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration) 4. Informed consent from patient Exclusion Criteria: 1. Delirium at hospital admission 2. Non-complex or off-pump cardiac surgery 3. Known allergy/hypersensitivity to insulin or formulation excipients 4. Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils) 5. Participating in other investigational medication trial

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Conditions

The condition(s) this trial relates to.

Emergence Delirium delirium prevention target

As listed by the trial registrant

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

Delirium, postoperative

Contacts and locations

Locations

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525GA, Netherlands

More trials for these conditions

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