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

Not Applicable

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Other: Different anesthesia methods, namely local anesthesia and general anesthesia

• Registration Number: NCT06416657
• Lead Sponsor: Ming Lv

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-11
• Study First Posted: 2024-05-16
• Study Start: 2024-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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 <15mm;
4. Baseline mRS score ≤2;
5. Patients voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria

1. The patient's aneurysm is 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. Cases treated with coils assisted therapy
3. Those who are allergic to any components of the anesthetic drugs;
4. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
5. Pregnant and lactating female patients;
6. Patients with severe renal disease resulting in renal insufficiency (glomerular filtration rate <30ml/(min﹒1.73m2));
7. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
8. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
9. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
10. Patients who are participating in clinical trials of other drugs or devices;
11. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia group	Different anesthesia methods, namely local anesthesia and general anesthesia	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.
Local anesthesia group	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.

Primary Outcome Measures

Name	Time	Method
Good neurologic status	90 days after intervention	Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)

Secondary Outcome Measures

Name	Time	Method
Newly developed cerebral ischemic foci	Within 48 hours of flow diverter placement	Determination was based on DWI sequences of cranial MRI
Status of cognitive function	90 days after intervention	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	7 days after intervention	The perioperative period is defined as up to 7 days after the intervention
Overall complication rate at 90 days postoperatively	90 days after intervention	Overall complication rate at 90 days postoperatively
Mortality at 90 days post-intervention	90 days after intervention	Mortality at 90 days post-intervention
Proportion of local anesthesia converted to general anesthesia during interventional procedures	Immediately after intervention	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.
Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time	Immediately after surgery	Record the above times in the immediate postoperative period
Incidence of intraoperative vasospasm	Immediately after surgery	Incidence of intraoperative vasospasm
Pain scores at 12 hours postoperatively	12 hours after intervention	Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)
Pain medication use within 24 hours after surgery	24 hours after intervention	Pain medication use within 24 hours after surgery
Length of hospitalization	Until the patient was discharged from the hospital, an average of 1 week.	Length of hospitalization
Hospitalization costs	Until the patient was discharged from the hospital, an average of 1 week.	Hospitalization costs

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China