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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416657
• Other study ID #: dragontiger
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Linggen Dong, MD
• Phone: 18844738529
• Email: donglinggen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ming Lv

References & Publications (21)

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Hanel RA, Kallmes DF, Lopes DK, Nelson PK, Siddiqui A, Jabbour P, Pereira VM, Szikora Istvan I, Zaidat OO, Bettegowda C, Colby GP, Mokin M, Schirmer C, Hellinger FR, Given Ii C, Krings T, Taussky P, Toth G, Fraser JF, Chen M, Priest R, Kan P, Fiorella D, — View Citation

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McDonald JS, Brinjikji W, Rabinstein AA, Cloft HJ, Lanzino G, Kallmes DF. Conscious sedation versus general anaesthesia during mechanical thrombectomy for stroke: a propensity score analysis. J Neurointerv Surg. 2015 Nov;7(11):789-94. doi: 10.1136/neurint — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good neurologic status	Defined as an mRS score of =2 (i.e., asymptomatic or without significant disability)	90 days after intervention
Secondary	Newly developed cerebral ischemic foci	Determination was based on DWI sequences of cranial MRI	Within 48 hours of flow diverter placement
Secondary	Status of cognitive function	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
Secondary	Postoperative perioperative complication rate	The perioperative period is defined as up to 7 days after the intervention	7 days after intervention
Secondary	Overall complication rate at 90 days postoperatively	Overall complication rate at 90 days postoperatively	90 days after intervention
Secondary	Mortality at 90 days post-intervention	Mortality at 90 days post-intervention	90 days after intervention
Secondary	Proportion of local anesthesia converted to general anesthesia during interventional procedures	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
Secondary	Anesthesia induction time, time from femoral artery puncture to femoral artery suture, anesthesia recovery time, and total operative time	Record the above times in the immediate postoperative period	Immediately after surgery
Secondary	Rate of complete occlusion of aneurysms	Assessment of aneurysm occlusion status using O'Kelly-Marotta (OKM) grading	One year after intervention
Secondary	Incidence of intraoperative vasospasm	Incidence of intraoperative vasospasm	Immediately after surgery
Secondary	Pain scores at 12 hours postoperatively	Measured with a VAS ranging from 0 (no pain) to 10 (intolerable)	12 hours after intervention
Secondary	Pain medication use within 24 hours after surgery	Pain medication use within 24 hours after surgery	24 hours after intervention
Secondary	Length of hospitalization	Length of hospitalization	Until the patient was discharged from the hospital, an average of 1 week.
Secondary	Hospitalization costs	Hospitalization costs	Until the patient was discharged from the hospital, an average of 1 week.