Comparing general and local anesthesia for treating unruptured brain aneurysms

General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial

This study is testing whether using local anesthesia instead of general anesthesia is a safe and effective option for adults with unruptured brain aneurysms during treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06416657 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of using general anesthesia versus local anesthesia during the placement of flow diverters for treating unruptured intracranial aneurysms. The study aims to determine if local anesthesia can be a viable alternative to general anesthesia, which is currently the standard practice. Participants will be adults aged 18 to 75 with specific criteria related to their aneurysms, and the trial will assess technical success rates and complication rates associated with each anesthesia method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with untreated unruptured intracranial aneurysms that meet specific size and health criteria.

Not a fit: Patients with severe symptoms related to their aneurysms, those who are pregnant or lactating, or individuals with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and less invasive anesthesia option for patients undergoing treatment for unruptured intracranial aneurysms.

How similar studies have performed: Previous studies have shown the feasibility of using local anesthesia for similar procedures, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Linggen Dong, MD

Conditions Intracranial Aneurysm; Unruptured intracranial aneurysm; Flow diverter; General anesthesia; Local anesthesia