## Protocol Section
### Identification Module
**NCT ID:** NCT06416657

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

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

#### Organization Study ID Info
**ID:** dragontiger
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tiantan Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ming Lv

#### Responsible Party

**Investigator Affiliation:** Beijing Tiantan Hospital

**Investigator Full Name:** Ming Lv

**Investigator Title:** Principal Investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Intracranial Aneurysm

**Keywords:**

- Unruptured intracranial aneurysm

- Flow diverter

- General anesthesia

- Local anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**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.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 188

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in the local anesthesia group received only local anesthesia at the femoral artery puncture site without anesthesia drugs such as conscious sedation.

**Intervention Names:**

- Other: Different anesthesia methods, namely local anesthesia and general anesthesia

**Label:** Local anesthesia group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Different anesthesia methods, namely local anesthesia and general anesthesia

**Label:** General anesthesia group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- General anesthesia group

- Local anesthesia group

**Description:** 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.

**Name:** Different anesthesia methods, namely local anesthesia and general anesthesia

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Good neurologic status

**Time Frame:** 90 days after intervention

#### Secondary Outcomes

**Description:** Determination was based on DWI sequences of cranial MRI

**Measure:** Newly developed cerebral ischemic foci

**Time Frame:** Within 48 hours of flow diverter placement

**Description:** 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.

**Measure:** Status of cognitive function

**Time Frame:** 90 days after intervention

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

**Measure:** Postoperative perioperative complication rate

**Time Frame:** 7 days after intervention

**Description:** Overall complication rate at 90 days postoperatively

**Measure:** Overall complication rate at 90 days postoperatively

**Time Frame:** 90 days after intervention

**Description:** Mortality at 90 days post-intervention

**Measure:** Mortality at 90 days post-intervention

**Time Frame:** 90 days after intervention

**Description:** 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.

**Measure:** Proportion of local anesthesia converted to general anesthesia during interventional procedures

**Time Frame:** Immediately after intervention

**Description:** Record the above times in the immediate postoperative period

**Measure:** Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time

**Time Frame:** Immediately after surgery

**Description:** Assessment of aneurysm occlusion status using O'Kelly-Marotta (OKM) grading

**Measure:** Rate of complete occlusion of aneurysms

**Time Frame:** One year after intervention

**Description:** Incidence of intraoperative vasospasm

**Measure:** Incidence of intraoperative vasospasm

**Time Frame:** Immediately after surgery

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

**Measure:** Pain scores at 12 hours postoperatively

**Time Frame:** 12 hours after intervention

**Description:** Pain medication use within 24 hours after surgery

**Measure:** Pain medication use within 24 hours after surgery

**Time Frame:** 24 hours after intervention

**Description:** Length of hospitalization

**Measure:** Length of hospitalization

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

**Description:** Hospitalization costs

**Measure:** Hospitalization costs

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

### Eligibility Module

**Eligibility Criteria:** 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 \&lt;15mm;
4. Baseline mRS score ≤2;
5. Patients voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

1. The patient\&#39;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 \&lt;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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** donglinggen@163.com

**Name:** Linggen Dong, MD

**Phone:** 18844738529

**Role:** CONTACT

**Contact 2:**

**Email:** dragontiger@163.com

**Name:** Ming Lv, Ph D.

**Phone:** 13701376177

**Role:** CONTACT

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000020765

- Term: Intracranial Arterial Diseases

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4113

- Name: Aneurysm

- Relevance: HIGH

- As Found: Aneurysm

- ID: M5781

- Name: Intracranial Aneurysm

- Relevance: HIGH

- As Found: Intracranial Aneurysm

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22521

- Name: Intracranial Arterial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002532

- Term: Intracranial Aneurysm

- ID: D000000783

- Term: Aneurysm

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M1696

- Name: Remifentanil

- Relevance: LOW

- As Found: Unknown

- ID: M10576

- Name: Isoproterenol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
