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Sleep or awake? new study tests best anesthesia for brain aneurysm treatment

NCT ID NCT06416657

Knowledge-focused Sponsor: Ming Lv Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 2 times

Summary

This study compares general anesthesia (being fully asleep) versus local anesthesia (awake but numb) for repairing unruptured brain aneurysms with a flow diverter device. About 188 adults with small aneurysms will be randomly assigned to one of the two anesthesia methods. The goal is to see which approach leads to better recovery and fewer complications.

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 188 people

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

Started

Jun 2024

Expected to finish

Dec 2026

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

18 to 80 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. Age ≥18 years old and ≤80 years old, gender is not limited; 2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA; 3. UIA maximum diameter \<15mm; 4. Baseline mRS score ≤2; 5. UIAs planned for treated with PED; 6. Patients voluntarily participated in this study and signed an informed consent form. Exclusion Criteria: 1. The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery; 2. Those who are allergic to any components of the anesthetic drugs; 3. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3; 4. Pregnant and lactating female patients; 5. Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min) before randomisation; 6. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.); 7. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination; 8. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year; 9. Patients who are participating in clinical trials of other drugs or devices; 10. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

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

Intracranial aneurysm

How to take part

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

  1. The places running it

    1 site. 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

  • Beijing Tiantan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100010, China

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