Back to resultsAcupoint Stimulation and Cranial Endovascular Treatment (ASSET)
Primary Purpose
Cerebral Aneurysm
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous electrical acupoint stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Aneurysm focused on measuring transcutaneous electrical acupoint stimulation, endovascular treatment
Eligibility Criteria
Inclusion Criteria:
- age ≥18 years
- patients scheduled for cranial endovascular treatment
Exclusion Criteria:
- 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
Sites / Locations
- Xijing hospital, Fourth military medical universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
transcutaneous electrical acupoint stimulation
Control
Arm Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
mortality by 30 days after surgery
mortality by 3 months after surgery
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
mortality by 6 months after surgery
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
duration of postoperative in-hospital stay
serum interleukin-6 level at the end of the surgery
serum tumor necrosis factor-α level at the end of the surgery
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
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.
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.
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
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05413460
Brief Title
Acupoint Stimulation and Cranial Endovascular Treatment
Acronym
ASSET
Official Title
Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhihong LU
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
Keywords
transcutaneous electrical acupoint stimulation, endovascular treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcutaneous electrical acupoint stimulation
Arm Type
Experimental
Arm Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical acupoint stimulation
Other Intervention Name(s)
TEAS
Intervention Description
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
Primary Outcome Measure Information:
Title
number of patients with major in-hospital postoperative complications
Description
major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma
Time Frame
from end of surgery to discharge from hospital, in an average of 7 days
Secondary Outcome Measure Information:
Title
mortality by 30 days after surgery
Time Frame
from end of surgery to 30 days after surgery, in a total of 30 days
Title
mortality by 3 months after surgery
Time Frame
from end of surgery to 3 months after surgery, in a total of 3 months
Title
number of patients with major postoperative complications by 3 months after surgery
Description
major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma
Time Frame
from end of surgery to 3 months after surgery, in a total of 3 months
Title
mortality by 6 months after surgery
Time Frame
from end of surgery to 6 months after surgery, in a total of 6 months
Title
number of patients with major postoperative complications by 6 months after surgery
Description
major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma
Time Frame
from end of surgery to 6 months after surgery, in a total of 6 months
Title
duration of postoperative in-hospital stay
Time Frame
from end of surgery to discharge from hospital, in an average of 7 days
Title
serum interleukin-6 level at the end of the surgery
Time Frame
at end of the surgery
Title
serum tumor necrosis factor-α level at the end of the surgery
Time Frame
at end of the surgery
Title
episodes of hypotension during surgery
Description
hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute
Time Frame
from start of surgery to end of surgery, in an average of 2 hours
Title
Score of Mini-mental State Examination at 1 day after surgery
Description
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.
Time Frame
at 24h after the end of surgery
Title
Score of Mini-mental State Examination at 3 days after surgery
Description
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.
Time Frame
at 72h after the end of surgery
Title
visual analog scale of pain at 1 day after surgery
Description
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
Time Frame
at 24h after the end of surgery
Title
visual analog scale of pain at 3 days after surgery
Description
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
Time Frame
at 72h after the end of surgery
Title
Quality of recovery score at 3 days after surgery
Description
Quality of recovery-40 is a questionnaire consisted of 40 questions about the recovery of the patient. Higher score means better recovery.
Time Frame
at 72h after the end of surgery
Title
Rankin's score at 3 days after surgery
Description
Rankin's score consists of class of 6 levels and is used for evaluation of neurologic function. Higher score means worse outcome.
Time Frame
at 72h after the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥18 years
patients scheduled for cranial endovascular treatment
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Lu
Phone
+8613891975018
Email
deerlu23@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Minjuan Zhang
Phone
8684775343
Email
947391349@qq.com
Facility Information:
Facility Name
Xijing hospital, Fourth military medical university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Lu
Phone
13891975018
Email
deerlu23@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35450928
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.
Results Reference
background
PubMed Identifier
34806930
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.
Results Reference
background
PubMed Identifier
34538090
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.
Results Reference
background
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Acupoint Stimulation and Cranial Endovascular Treatment
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