Acupoint Stimulation and Cranial Endovascular Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-26

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.

Study Groups

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transcutaneous electrical acupoint stimulation

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

Group Type EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transcutaneous electrical acupoint stimulation

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

Intervention Type DEVICE

Other Intervention Names

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TEAS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No