Clinical trial NCT05413460: Acupoint Stimulation and Cranial Endovascular Treatment
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Aneurysm
Keywords: transcutaneous electrical acupoint stimulation
endovascular treatment
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of patients with major in-hospital postoperative complications
timeFrame: from end of surgery to discharge from hospital, in an average of 7 days
Secondary outcomes:
measure: mortality by 30 days after surgery
timeFrame: from end of surgery to 30 days after surgery, in a total of 30 days
measure: mortality by 3 months after surgery
timeFrame: from end of surgery to 3 months after surgery, in a total of 3 months
measure: number of patients with major postoperative complications by 3 months after surgery
timeFrame: from end of surgery to 3 months after surgery, in a total of 3 months
measure: mortality by 6 months after surgery
timeFrame: from end of surgery to 6 months after surgery, in a total of 6 months
measure: number of patients with major postoperative complications by 6 months after surgery
timeFrame: from end of surgery to 6 months after surgery, in a total of 6 months
measure: duration of postoperative in-hospital stay
timeFrame: from end of surgery to discharge from hospital, in an average of 7 days
measure: serum interleukin-6 level at the end of the surgery
timeFrame: at end of the surgery
measure: serum tumor necrosis factor-α level at the end of the surgery
timeFrame: at end of the surgery
measure: episodes of hypotension during surgery
timeFrame: from start of surgery to end of surgery, in an average of 2 hours
measure: Score of Mini-mental State Examination at 1 day after surgery
timeFrame: at 24h after the end of surgery
measure: Score of Mini-mental State Examination at 3 days after surgery
timeFrame: at 72h after the end of surgery
measure: visual analog scale of pain at 1 day after surgery
timeFrame: at 24h after the end of surgery
measure: visual analog scale of pain at 3 days after surgery
timeFrame: at 72h after the end of surgery
measure: Quality of recovery score at 3 days after surgery
timeFrame: at 72h after the end of surgery
measure: Rankin's score at 3 days after surgery
timeFrame: at 72h after the end of surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital, Fourth military medical university
state: Shaanxi
Study officials:
References:
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. 2023 May;15(5):478-482. doi: 10.1136/neurintsurg-2022-018846. Epub 2022 Apr 21.
citation: 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.
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.