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

Ming Lv188 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

188

Conditions

Intracranial Aneurysm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Good neurologic status

Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)

Time frame: 90 days after intervention

Secondary Outcomes

Newly developed cerebral ischemic foci

Determination was based on DWI sequences of cranial MRI

Time frame: Within 48 hours of flow diverter placement

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.

Time frame: 90 days after intervention

Postoperative perioperative complication rate

The perioperative period is defined as up to 7 days after the intervention

Time frame: 7 days after intervention

Overall complication rate at 90 days postoperatively

Time frame: 90 days after intervention

Mortality at 90 days post-intervention

Time frame: 90 days after intervention

Proportion of local anesthesia converted to general anesthesia during interventional procedures

For patient safety, patients in LA will be referred to GA if they develop the following conditions a) The patient becomes comatose and unconscious; b) Glasgow coma scale (GCS) \<8; c) EtCO2 ≥ 60 mmHg or SpO2 \< 94% despite supplemental oxygen; d) Patient has vomiting, vertigo, agitation that is not controlled by antiemetics and sedation; e) Seizures; f) Complications of endovascular therapy, such as intracerebral hemorrhage from a ruptured aneurysm or SAH.

Time frame: Immediately after intervention

Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time

Record the above times in the immediate postoperative period

Time frame: Immediately after surgery

Incidence of intraoperative vasospasm

Time frame: Immediately after surgery

Pain scores at 12 hours postoperatively

Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)

Time frame: 12 hours after intervention

Pain medication use within 24 hours after surgery

Time frame: 24 hours after intervention

Length of hospitalization

Time frame: Until the patient was discharged from the hospital, an average of 1 week.

Hospitalization costs

Time frame: Until the patient was discharged from the hospital, an average of 1 week.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts