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.
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;
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;
Parallel
Different anesthesia methods, namely local anesthesia and general anesthesia
Other interventionPatients 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.
Good neurologic status
Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)
Newly developed cerebral ischemic foci
Determination was based on DWI sequences of cranial MRI
Status of cognitive function
Cognitive functioning status assessed by the Montreal Cognitive Assessment (MoCA). The MoCA was developed by Prof. Nasreddine in 2004 as a rapid screening tool for mild cognitive impairment.The MoCA has a total score of 30, with a minimum score of 0. Higher scores indicate better cognitive functioning. By scoring each domain, more detailed information can be obtained to determine the extent of deficits and abnormalities in cognitive functioning. In general, a score of 26 and above can be considered normal cognitive functioning, while a score below 26 may indicate the presence of cognitive impairment or dementia. 18-26 is considered mild cognitive impairment, 10-17 is considered moderate cognitive impairment, and \<10 is considered severe cognitive impairment.
Postoperative perioperative complication rate
The perioperative period is defined as up to 7 days after the intervention
Overall complication rate at 90 days postoperatively
Overall complication rate at 90 days postoperatively
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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
