General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter: an Exploratory Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age ≥18 years old and ≤80 years old, gender is not limited;

• Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;

• UIA maximum diameter \<15mm;

• Baseline mRS score ≤2;

• UIAs planned for treated with PED;

• Patients voluntarily participated in this study and signed an informed consent form.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Linggen Dong, MD
donglinggen@163.com
18844738529
Backup
Ming Lv, Ph D.
dragontiger@163.com
13701376177
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 188
Treatments
Experimental: Local anesthesia group
Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.
Active_comparator: General anesthesia group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Beijing Anzhen Hospital, Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University, Peking University Third Hospital, Peking University International Hospital, The Third Medical Center of Chinese PLA General Hospital, Beijing Chao Yang Hospital, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Beijing Sanbo Brain Hospital, The Second Artillery General Hospital
Leads: Ming Lv

This content was sourced from clinicaltrials.gov