Acupoint Stimulation and Cranial Endovascular Treatment
ASSET
Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedDecember 6, 2022
December 1, 2022
11 months
May 25, 2022
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
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
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
- +10 more secondary outcomes
Study Arms (2)
transcutaneous electrical acupoint stimulation
EXPERIMENTALElectrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Control
NO INTERVENTIONElectrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.
Interventions
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Eligibility Criteria
You may qualify if:
- age ≥18 years
- patients scheduled for cranial endovascular treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhihong LUlead
Study Sites (1)
Xijing hospital, Fourth military medical university
Xi'an, Shaanxi, 710032, China
Related Publications (3)
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.
PMID: 35450928BACKGROUNDCampbell 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.
PMID: 34806930BACKGROUNDSamuels 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.
PMID: 34538090BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 25, 2022
First Posted
June 10, 2022
Study Start
July 26, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
December 6, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share