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NCT Number: NCT06416657

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

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Location status: Recruiting

Location contact

Ming Lv, MD,PhD

CONTACT

[email protected]

13701376177

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Different anesthesia methods, namely local anesthesia and general anesthesia

Other

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.

Primary outcomes

  1. Good neurologic status

    Time frame: 90 days after intervention

    Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)

Secondary outcomes

  1. Newly developed cerebral ischemic foci

    Time frame: Within 48 hours of flow diverter placement

    Determination was based on DWI sequences of cranial MRI

  2. Status of cognitive function

    Time frame: 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.

  3. Postoperative perioperative complication rate

    Time frame: 7 days after intervention

    The perioperative period is defined as up to 7 days after the intervention

  4. Overall complication rate at 90 days postoperatively

    Time frame: 90 days after intervention

    Overall complication rate at 90 days postoperatively

  5. Mortality at 90 days post-intervention

    Time frame: 90 days after intervention

    Mortality at 90 days post-intervention

  6. Proportion of local anesthesia converted to general anesthesia during interventional procedures

    Time frame: 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.

  7. Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time

    Time frame: Immediately after surgery

    Record the above times in the immediate postoperative period

  8. Incidence of intraoperative vasospasm

    Time frame: Immediately after surgery

    Incidence of intraoperative vasospasm

  9. Pain scores at 12 hours postoperatively

    Time frame: 12 hours after intervention

    Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)

  10. Pain medication use within 24 hours after surgery

    Time frame: 24 hours after intervention

    Pain medication use within 24 hours after surgery

  11. Length of hospitalization

    Time frame: Until the patient was discharged from the hospital, an average of 1 week.

    Length of hospitalization

  12. Hospitalization costs

    Time frame: Until the patient was discharged from the hospital, an average of 1 week.

    Hospitalization costs

Study contacts

Contact information is provided by the study sponsor or research team.

Linggen Dong, MD

CONTACT

[email protected]

18844738529

Ming Lv, Ph D.

CONTACT

[email protected]

13701376177

Sponsors and collaborators

Lead sponsor

Ming Lv

Other

Collaborators

  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Peking University International Hospital
  • The Affiliated Lianyungang Hospital of Xuzhou Medical University
  • The Second Artillery General Hospital
  • Third Medical Center of Chinese PLA General Hospital

Registry information

Official study title

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

Acronym: GALA-FD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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