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

May 11, 2024 updated by: Ming Lv

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old and ≤75 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. Patients voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

  1. The patient's aneurysm is 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. Cases treated with coils assisted therapy
  3. Those who are allergic to any components of the anesthetic drugs;
  4. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
  5. Pregnant and lactating female patients;
  6. Patients with severe renal disease resulting in renal insufficiency (glomerular filtration rate <30ml/(min﹒1.73m2));
  7. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
  8. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
  9. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
  10. Patients who are participating in clinical trials of other drugs or devices;
  11. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Good neurologic status
Time Frame: 90 days after intervention
Defined as an mRS score of ≤2 (i.e., asymptomatic or without significant disability)
90 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newly developed cerebral ischemic foci
Time Frame: Within 48 hours of flow diverter placement
Determination was based on DWI sequences of cranial MRI
Within 48 hours of flow diverter placement
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.
90 days after intervention
Postoperative perioperative complication rate
Time Frame: 7 days after intervention
The perioperative period is defined as up to 7 days after the intervention
7 days after intervention
Overall complication rate at 90 days postoperatively
Time Frame: 90 days after intervention
Overall complication rate at 90 days postoperatively
90 days after intervention
Mortality at 90 days post-intervention
Time Frame: 90 days after intervention
Mortality at 90 days post-intervention
90 days after intervention
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.
Immediately after intervention
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
Immediately after surgery
Rate of complete occlusion of aneurysms
Time Frame: One year after intervention
Assessment of aneurysm occlusion status using O'Kelly-Marotta (OKM) grading
One year after intervention
Incidence of intraoperative vasospasm
Time Frame: Immediately after surgery
Incidence of intraoperative vasospasm
Immediately after surgery
Pain scores at 12 hours postoperatively
Time Frame: 12 hours after intervention
Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)
12 hours after intervention
Pain medication use within 24 hours after surgery
Time Frame: 24 hours after intervention
Pain medication use within 24 hours after surgery
24 hours after intervention
Length of hospitalization
Time Frame: Until the patient was discharged from the hospital, an average of 1 week.
Length of hospitalization
Until the patient was discharged from the hospital, an average of 1 week.
Hospitalization costs
Time Frame: Until the patient was discharged from the hospital, an average of 1 week.
Hospitalization costs
Until the patient was discharged from the hospital, an average of 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming Lv

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dragontiger

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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