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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMing Lv

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years old and ≤80 years old, gender is not limited;

Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;

UIA maximum diameter <15mm;

Baseline mRS score ≤2;

Disqualifiers

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;

Those who are allergic to any components of the anesthetic drugs;

Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;

Pregnant and lactating female patients;

Trial design

Treatments tested in this trial

  • Different anesthesia methods, namely local anesthesia and general anesthesia

Treatment groups

188 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ming Lv

Lead sponsor

Beijing Tiantan Hospital

Sponsor institution

Beijing Chao Yang Hospital

Collaborator

Peking University International Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Third Medical Center of Chinese PLA General Hospital

Collaborator

The Second Artillery General Hospital

Collaborator