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

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

Interventions

OTHER

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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital

  collaborator OTHER

• Peking University International Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• The Affiliated Lianyungang Hospital of Xuzhou Medical University

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• The Third Medical Center of Chinese PLA General Hospital

  collaborator UNKNOWN

• The Second Artillery General Hospital

  collaborator OTHER

• Ming Lv

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-11-12

Completion

2026-06-01

Countries

• China

Study Locations