General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter

NCT ID: NCT06416657

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-01

Brief Summary

The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local anesthesia group

Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.

Group Type: EXPERIMENTAL

Different anesthesia methods, namely local anesthesia and general anesthesia

Intervention Type: OTHER

Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.

Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.

General anesthesia group

Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.

Group Type: ACTIVE_COMPARATOR

Different anesthesia methods, namely local anesthesia and general anesthesia

Intervention Type: OTHER

Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.

Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.

Interventions

Different anesthesia methods, namely local anesthesia and general anesthesia

Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.

Patients in the general anesthesia group received not only local anesthesia at the femoral artery puncture site, but also fast-induction anesthesia with tracheal intubation or laryngeal mask insertion using isoproterenol, remifentanil, and muscle relaxants.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

Peking University International Hospital

OTHER

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Lianyungang Hospital of Xuzhou Medical University

UNKNOWN

Sponsor Role: collaborator

Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

UNKNOWN

Sponsor Role: collaborator

The Third Medical Center of Chinese PLA General Hospital

UNKNOWN

Sponsor Role: collaborator

The Second Artillery General Hospital

OTHER

Sponsor Role: collaborator

Ming Lv

OTHER

Sponsor Role: lead

Responsible Party

Ming Lv

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Linggen Dong, MD

Role: CONTACT

donglinggen@163.com

18844738529

Ming Lv, Ph D.

Role: CONTACT

dragontiger@163.com

13701376177

Facility Contacts

Ming Lv, MD,PhD

Role: primary

dragontiger@163.com

13701376177

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Other Identifiers

dragontiger

Identifier Type: -

Identifier Source: org_study_id