Acupoint Stimulation and Cranial Endovascular Treatment

Study Overview
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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.

Official Title
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Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment

Conditions
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Cerebral Aneurysm

Intervention / Treatment
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* Device: transcutaneous electrical acupoint stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years patients scheduled for cranial endovascular treatment Exclusion Criteria: American Society of Anesthesiologists class Ⅲ or higher Hunt-Hess class Ⅲ or higher body mass index (BMI) < 18 kg/㎡ or > 30kg/㎡ large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm posterior circulation infarction recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure injury or infection of the skin around the acupoint area participate in other clinical researchers within 3 months history of neurological or psychiatric diseases patients with implanted electrophysiological device use of sedative or analgesics before surgery patients with difficulty in communication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous electrical acupoint stimulation<br>Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery. | Device: transcutaneous electrical acupoint stimulation<br>* Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.<br>* Other names: TEAS;|
| No Intervention: Control<br>Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with major in-hospital postoperative complications | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma | from end of surgery to discharge from hospital, in an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality by 30 days after surgery |  | from end of surgery to 30 days after surgery, in a total of 30 days | 
| mortality by 3 months after surgery |  | from end of surgery to 3 months after surgery, in a total of 3 months | 
| number of patients with major postoperative complications by 3 months after surgery | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma | from end of surgery to 3 months after surgery, in a total of 3 months | 
| mortality by 6 months after surgery |  | from end of surgery to 6 months after surgery, in a total of 6 months | 
| number of patients with major postoperative complications by 6 months after surgery | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma | from end of surgery to 6 months after surgery, in a total of 6 months | 
| duration of postoperative in-hospital stay |  | from end of surgery to discharge from hospital, in an average of 7 days | 
| serum interleukin-6 level at the end of the surgery |  | at end of the surgery | 
| serum tumor necrosis factor-α level at the end of the surgery |  | at end of the surgery | 
| episodes of hypotension during surgery | hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute | from start of surgery to end of surgery, in an average of 2 hours | 
| Score of Mini-mental State Examination at 1 day after surgery | A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function. | at 24h after the end of surgery | 
| Score of Mini-mental State Examination at 3 days after surgery | A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function. | at 72h after the end of surgery | 
| visual analog scale of pain at 1 day after surgery | visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain | at 24h after the end of surgery | 
| visual analog scale of pain at 3 days after surgery | visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain | at 72h after the end of surgery | 
| Quality of recovery score at 3 days after surgery | Quality of recovery-40 is a questionnaire consisted of 40 questions about the recovery of the patient. Higher score means better recovery. | at 72h after the end of surgery | 
| Rankin's score at 3 days after surgery | Rankin's score consists of class of 6 levels and is used for evaluation of neurologic function. Higher score means worse outcome. | at 72h after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous electrical acupoint stimulation, endovascular treatment