Acupoint Stimulation and Cranial Endovascular Treatment

Not Applicable

Recruiting

• Conditions: Cerebral Aneurysm
• Interventions: Device: transcutaneous electrical acupoint stimulation

• Registration Number: NCT05413460
• Lead Sponsor: Zhihong LU

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Study Start: 2022-07-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcutaneous electrical acupoint stimulation	transcutaneous electrical acupoint stimulation	Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
serum interleukin-6 level at the end of the surgery	at end of the surgery
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.
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
serum tumor necrosis factor-α level at the end of the surgery	at end of the surgery
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 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
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
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
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.
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
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.

Trial Locations

Locations (1)

Xijing hospital, Fourth military medical university; 🇨🇳 Xi'an, Shaanxi, China