Cerebral Aneurysm
Conditions
Keywords
transcutaneous electrical acupoint stimulation, endovascular treatment
Brief summary
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.
Interventions
DEVICEtranscutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Sponsors
Zhihong LU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with major in-hospital postoperative complications | from end of surgery to discharge from hospital, in an average of 7 days | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | from end of surgery to 3 months after surgery, in a total of 3 months | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma |
| 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 | from end of surgery to 6 months after surgery, in a total of 6 months | major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma |
| 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 | — |
| Rankin's score at 3 days after surgery | at 72h after the end of surgery | Rankin's score consists of class of 6 levels and is used for evaluation of neurologic function. Higher score means worse outcome. |
| episodes of hypotension during surgery | from start of surgery to end of surgery, in an average of 2 hours | hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute |
| Score of Mini-mental State Examination at 1 day after surgery | at 24h after the end of 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. |
| Score of Mini-mental State Examination at 3 days after surgery | at 72h after the end of 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. |
| visual analog scale of pain at 1 day after surgery | at 24h after the end of 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 |
| visual analog scale of pain at 3 days after surgery | at 72h after the end of 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 |
| Quality of recovery score at 3 days after surgery | at 72h after the end of surgery | Quality of recovery-40 is a questionnaire consisted of 40 questions about the recovery of the patient. Higher score means better recovery. |
| serum tumor necrosis factor-α level at the end of the surgery | at end of the surgery | — |
Countries
China
Contacts
Primary ContactZhihong Lu
Backup ContactMinjuan Zhang
Outcome results
None listed