Intracranial Aneurysm
Conditions
Keywords
Unruptured intracranial aneurysm, Flow diverter, General anesthesia, Local anesthesia
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.
Interventions
OTHERDifferent 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.
Sponsors
Ming Lv
Beijing Chao Yang Hospital
Peking University International Hospital
Beijing Anzhen Hospital
The Affiliated Lianyungang Hospital of Xuzhou Medical University
First Affiliated Hospital, Sun Yat-Sen University
Third Medical Center of Chinese PLA General Hospital
The Second Artillery General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Researchers responsible for outcome assessment are unaware of the allocation of anesthesia modalities, but anesthesiologists and neurosurgeons are aware of the allocation of anesthesia modalities because they need to be involved in the safe administration of general or local anesthesia and related medical care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old and ≤80 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. UIAs planned for treated with PED; 6. 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. Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min) before randomisation; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Good neurologic status | 90 days after intervention | Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 24 hours postoperatively | 24 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 |
Countries
China
Contacts
CONTACTLinggen Dong, MD
CONTACTMing Lv, Ph D.
Outcome results
None listed