Clinical trial NCT06416657: General Anesthesia Vs Local Anesthesia for Endovascular Treatment in Patients with Unruptured Intracranial Aneurysm Using Flow Diverter
Official title: General Anesthesia Vs Local Anesthesia for Endovascular Treatment in Patients with Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Unruptured intracranial aneurysm
Flow diverter
General anesthesia
Local anesthesia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old and ≤75 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 \&amp;lt;15mm;
4. Baseline mRS score ≤2;
5. 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. Patients with severe renal disease resulting in renal insufficiency (glomerular filtration rate \&amp;lt;30ml/(min﹒1.73m2));
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.

Primary outcomes:
measure: Good neurologic status
timeFrame: 90 days after intervention
Secondary outcomes:
measure: Newly developed cerebral ischemic foci
timeFrame: Within 48 hours of flow diverter placement
measure: Status of cognitive function
timeFrame: 90 days after intervention
measure: Postoperative perioperative complication rate
timeFrame: 7 days after intervention
measure: Overall complication rate at 90 days postoperatively
timeFrame: 90 days after intervention
measure: Mortality at 90 days post-intervention
timeFrame: 90 days after intervention
measure: Proportion of local anesthesia converted to general anesthesia during interventional procedures
timeFrame: Immediately after intervention
measure: Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time
timeFrame: Immediately after surgery
measure: Incidence of intraoperative vasospasm
timeFrame: Immediately after surgery
measure: Pain scores at 12 hours postoperatively
timeFrame: 12 hours after intervention
measure: Pain medication use within 24 hours after surgery
timeFrame: 24 hours after intervention
measure: Length of hospitalization
timeFrame: Until the patient was discharged from the hospital, an average of 1 week.
measure: Hospitalization costs
timeFrame: Until the patient was discharged from the hospital, an average of 1 week.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
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