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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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. 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.

Первичные конечные точки

• Good neurologic status [Срок оценки: 90 days after intervention]

Вторичные конечные точки (12)

• Newly developed cerebral ischemic foci [Срок оценки: Within 48 hours of flow diverter placement]
• Status of cognitive function [Срок оценки: 90 days after intervention]
• Postoperative perioperative complication rate [Срок оценки: 7 days after intervention]
• Overall complication rate at 90 days postoperatively [Срок оценки: 90 days after intervention]
• Mortality at 90 days post-intervention [Срок оценки: 90 days after intervention]
• Proportion of local anesthesia converted to general anesthesia during interventional procedures [Срок оценки: Immediately after intervention]
• Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time [Срок оценки: Immediately after surgery]
• Incidence of intraoperative vasospasm [Срок оценки: Immediately after surgery]
• Pain scores at 12 hours postoperatively [Срок оценки: 12 hours after intervention]
• Pain medication use within 24 hours after surgery [Срок оценки: 24 hours after intervention]
• Length of hospitalization [Срок оценки: Until the patient was discharged from the hospital, an average of 1 week.]
• Hospitalization costs [Срок оценки: Until the patient was discharged from the hospital, an average of 1 week.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• Those who are allergic to any components of the anesthetic drugs;
• Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
• Pregnant and lactating female patients;
• Severe hepatic dysfunction (ALT or AST >three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate <30 mL/min) before randomisation;
• Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
• Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
• Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
• Patients who are participating in clinical trials of other drugs or devices;
• Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Публикации

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• Griessenauer CJ, Shallwani H, Adeeb N, Gupta R, Rangel-Castilla L, Siddiqui AH, Levy EI, Boone MD, Thomas AJ, Ogilvy CS. Conscious Sedation Versus General Anesthesia for the Treatment of Cerebral Aneurysms with Flow Diversion: A Matched Cohort Study. World Neurosurg. 2017 Jun;102:1-5. doi: 10.1016/j.wneu.2017.02.111. Epub 2017 Mar 6. PMID 28279774
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• Kilic Y, Bas SS, Aykac O, Ozdemir AO. Nonoperating Room Anesthesia for Interventional Neuroangiographic Procedures: Outcomes of 105 Patients. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104495. doi: 10.1016/j.jstrokecerebrovasdis.2019.104495. Epub 2019 Dec 2. PMID 31806453
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• Park MS, Albuquerque FC, Nanaszko M, Sanborn MR, Moon K, Abla AA, McDougall CG. Critical assessment of complications associated with use of the Pipeline Embolization Device. J Neurointerv Surg. 2015 Sep;7(9):652-9. doi: 10.1136/neurintsurg-2014-011265. Epub 2014 Jun 26. PMID 24968879
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Идентификаторы

NCT: NCT06416657 · dragontiger

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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