Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis.
Huibin Kang, Yu Zhou, Bin Luo...
https://pubmed.ncbi.nlm.nih.gov/33447904Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06416657
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial
Led by Ming Lv · Updated on 2025-12-02
188
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
M
Ming Lv
Lead Sponsor
B
Beijing Chao Yang Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of two anesthesia methods, general anesthesia (GA) and local anesthesia (LA), in patients with unruptured intracranial aneurysm (UIA) undergoing flow diverter (FD) placement. UIA is a condition affecting 2%-7% of the population, and rupture can lead to high rates of disability and death. Although FD placement under GA is common, some studies suggest LA might be feasible with fewer complications, but these studies have limitations. This trial aims to provide more reliable evidence by comparing GA and LA in a randomized controlled design. Participants will be randomly assigned to one of two groups. The LA group will receive local anesthesia only at the femoral artery puncture site without sedation drugs. The GA group will receive local anesthesia plus fast-induction general anesthesia involving tracheal intubation or laryngeal mask insertion with medications like isoproterenol, remifentanil, and muscle relaxants. The study will closely monitor the procedure and anesthesia effects during and after the intervention. During the study, participants will be followed for 90 days after the FD placement. Researchers will assess neurological status, cognitive function, newly developed cerebral ischemic areas, complication rates, mortality, pain levels, anesthesia and operative times, vasospasm incidence, hospitalization length, and costs. Safety and effectiveness outcomes will be carefully recorded to understand the impact of anesthesia choice on patient recovery and procedure success.
CONDITIONS
Brief Title
General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 80 years or younger
- Patients with previously untreated unruptured intracranial aneurysm diagnosed by DSA, CTA, or MRA
- Unruptured intracranial aneurysm with maximum diameter less than 15 mm
- Baseline modified Rankin Scale (mRS) score 2 or lower
- Aneurysms planned to be treated with Pipeline Embolization Device (PED)
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Aneurysms located distal to anterior cerebral artery, middle cerebral artery M2 segment, or basilar artery
- Allergy to any components of anesthetic drugs
- Severe symptoms related to the target aneurysm with mRS score 3 or higher
- Pregnant or lactating females
- Severe liver dysfunction (ALT or AST more than three times normal) or severe kidney dysfunction (creatinine clearance less than 30 mL/min)
- Presence of metal implants such as cardiac stents, prosthetic valves, pacemakers, metal joints, steel plates, or non-removable metal dentures
- Known dementia, psychiatric diseases, or claustrophobia preventing MRI examination
- Other serious diseases with expected survival less than 1 year
- Participation in other drug or device clinical trials
- Any other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Until discharge, approximately 1 week
Participants receive either local anesthesia or general anesthesia during endovascular treatment for unruptured intracranial aneurysm using a flow diverter.
1 procedure visit and hospital stay
Follow-up
Duration - 90 days after intervention
Participants are monitored for neurologic status, cognitive function, complications, and recovery after the intervention.
Visits at 12 hours, 24 hours, 7 days, and 90 days post-intervention
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
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Research Team
L
Linggen Dong, MD
M
Ming Lv, Ph D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Leonardo Rangel-Castilla, Marshall C Cress, Stephan A Munich...
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Christoph J Griessenauer, Hussain Shallwani, Nimer Adeeb...
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Adnan H Siddiqui, Peter Kan, Adib A Abla...
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Alex Abou-Chebl, Ridwan Lin, Muhammad Shazam Hussain...
https://pubmed.ncbi.nlm.nih.gov/20395617Conscious sedation versus general anaesthesia during mechanical thrombectomy for stroke: a propensity score analysis.
Jennifer S McDonald, Waleed Brinjikji, Alejandro A Rabinstein...
https://pubmed.ncbi.nlm.nih.gov/25261440