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Awake during surgery? new study tests safer anesthesia for frail patients

NCT ID NCT07486336

Knowledge-focused Sponsor: Ente Ospedaliero Ospedali Galliera 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether keeping frail patients awake during abdominal surgery (using spinal anesthesia and light sedation) is safer than putting them fully asleep with general anesthesia. Researchers will enroll 100 people over 60 who are frail or have memory problems. The goal is to see if this approach can reduce confusion after surgery and is practical to study on a larger scale.

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 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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

60 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: * Age \> 60 years * Willingness to participate in the study and written informed consent * ASA physical status \> 2 * Frailty score \> 5 and/or AMT-10 \< 6 * Laparoscopic or robotic major elective abdominopelvic surgery Exclusion Criteria: * Patients undergoing open (laparotomic) or emergency surgery, or presenting contraindications to central locoregional (neuraxial) anesthesia, specifically: * coagulation disorders * severe spinal deformities * known allergy to local anesthetics * severe aortic stenosis * systemic sepsis * infection at the puncture site * Any systemic disease that, in the investigator's judgment, is not compatible with participation in the study

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Conditions

The condition(s) this trial relates to.

Emergence Delirium Frailty Postoperative Cognitive Complications

As listed by the trial registrant

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

Abdominal surgery FRAILY Postoperative cognitive dysfunction (POCD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AO di Circolo di Melegnano

    Vizzolo Predabissi, 20070, Italy

  • E.O. Ospedali Galliera

    Genova, 16128, Italy

More trials for these conditions

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