Acupoint Stimulation and Cranial Endovascular Treatment (ASSET)

Zhihong LU

Status: Enrolling

Conditions: Cerebral Aneurysm

Treatments: Device: transcutaneous electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05413460

XJH-A-20200730

Details and patient eligibility

About

In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥18 years
2. patients scheduled for cranial endovascular treatment

Exclusion criteria

1. American Society of Anesthesiologists class Ⅲ or higher
2. Hunt-Hess class Ⅲ or higher
3. body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡
4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
5. posterior circulation infarction
6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
8. injury or infection of the skin around the acupoint area
9. participate in other clinical researchers within 3 months
10. history of neurological or psychiatric diseases
11. patients with implanted electrophysiological device
12. use of sedative or analgesics before surgery
13. patients with difficulty in communication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 2 patient groups

transcutaneous electrical acupoint stimulation

Experimental group

Description:

Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Treatment:

Device: transcutaneous electrical acupoint stimulation

Control

No Intervention group

Description:

Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.