Acupoint Stimulation and Cranial Endovascular Treatment (ASSET)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Device: transcutaneous electrical acupoint stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minjuan Zhang; Phone Number: 8684775343; Email: 947391349@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital, Fourth Military Medical University
      • Contact: Zhihong Lu; Phone Number: 13891975018; Email: deerlu23@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcutaneous electrical acupoint stimulation; Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.	Device: transcutaneous electrical acupoint stimulation; Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.; Other Names: TEAS
No Intervention: Control; Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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	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
duration of postoperative in-hospital stay		from end of surgery to discharge from hospital, in an average of 7 days
serum interleukin-6 level at the end of the surgery		at end of the surgery
serum tumor necrosis factor-α level at the end of the surgery		at 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	from start of surgery to end of surgery, in an average of 2 hours
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Zhihong LU

Publications and helpful links

General Publications

• 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. pii: neurintsurg-2022-018846. doi: 10.1136/neurintsurg-2022-018846. [Epub ahead of print]
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: endovascular treatment; transcutaneous electrical acupoint stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: XJH-A-20200730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No