Acupoint Stimulation and Cranial Endovascular Treatment

Cerebral Aneurysm Clinical Trial

— ASSET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413460
• Other study ID #: XJH-A-20200730
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: Air Force Military Medical University, China
• Contact: Zhihong Lu
• Phone: +8613891975018
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age =18 years

2. patients scheduled for cranial endovascular treatment

Exclusion Criteria:

1. American Society of Anesthesiologists class ? or higher

2. Hunt-Hess class ? 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

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Locations

Country	Name	City	State
China	Xijing hospital, Fourth military medical university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

Country where clinical trial is conducted

China, 

References & Publications (3)

Campbell D, Deng C, McBryde F, Billing R, Diprose WK, Short TG, Frampton C, Brew S, Barber PA; MASTERSTROKE Study Group. Protocol for the MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischemic STROKE randomized clinical trial: The MASTERSTROKE trial. Int J Stroke. 2022 Aug;17(7):810-814. doi: 10.1177/17474930211059029. Epub 2021 Nov 22. — View Citation

Dhillon PS, Butt W, Podlasek A, McConachie N, Lenthall R, Nair S, Malik L, Hewson DW, Bhogal P, Makalanda HLD, James MA, Dineen RA, England TJ. Association between anesthesia modality and clinical outcomes following endovascular stroke treatment in the extended time window. J Neurointerv Surg. 2022 Apr 21:neurintsurg-2022-018846. doi: 10.1136/neurintsurg-2022-018846. Online ahead of print. — View Citation

Samuels N, van de Graaf RA, van den Berg CAL, Uniken Venema SM, Bala K, van Doormaal PJ, van der Steen W, Witvoet E, Boiten J, den Hertog H, Schonewille WJ, Hofmeijer J, Schreuder F, Schreuder TAHCML, van der Worp HB, Roos YBWEM, Majoie CBLM, Burke JF, van Es ACGM, van der Lugt A, Roozenbeek B, Lingsma HF, Dippel DWJ; MR CLEAN Registry Investigators. Blood Pressure in the First 6 Hours Following Endovascular Treatment for Ischemic Stroke Is Associated With Outcome. Stroke. 2021 Nov;52(11):3514-3522. doi: 10.1161/STROKEAHA.120.033657. Epub 2021 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mortality by 30 days after surgery		from end of surgery to 30 days after surgery, in a total of 30 days
Secondary	mortality by 3 months after surgery		from end of surgery to 3 months after surgery, in a total of 3 months
Secondary	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
Secondary	mortality by 6 months after surgery		from end of surgery to 6 months after surgery, in a total of 6 months
Secondary	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
Secondary	duration of postoperative in-hospital stay		from end of surgery to discharge from hospital, in an average of 7 days
Secondary	serum interleukin-6 level at the end of the surgery		at end of the surgery
Secondary	serum tumor necrosis factor-a level at the end of the surgery		at end of the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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