General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter (GALA-FD)

Ming Lv

Status: Enrolling

Conditions: Intracranial Aneurysm

Treatments: Other: Different anesthesia methods, namely local anesthesia and general anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06416657

dragontiger

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

188 participants in 2 patient groups

Local anesthesia group

Experimental group

Description:

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

Treatment:

Other: Different anesthesia methods, namely local anesthesia and general anesthesia

General anesthesia group

Active Comparator group

Description:

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.

Treatment:

Other: Different anesthesia methods, namely local anesthesia and general anesthesia