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

Zhihong LU1 site in 1 country158 target enrollmentJuly 26, 2022

ConditionsCerebral Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Aneurysm
Sponsor: Zhihong LU
Enrollment: 158
Locations: 1
Primary Endpoint: number of patients with major in-hospital postoperative complications
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 26, 2022

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhihong LU

Responsible Party

Sponsor Investigator

Principal Investigator

Zhihong LU

Professor

Air Force Military Medical University, China

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

Outcomes

Primary Outcomes

number of patients with major in-hospital postoperative complications

Time Frame: from end of surgery to discharge from hospital, in an average of 7 days

major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma

Secondary Outcomes

serum interleukin-6 level at the end of the surgery(at end of the surgery)
mortality by 6 months after surgery(from end of surgery to 6 months after surgery, in a total of 6 months)
Score of Mini-mental State Examination at 1 day after surgery(at 24h after the end of surgery)
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)
serum tumor necrosis factor-α level at the end of the surgery(at end of the surgery)
episodes of hypotension during surgery(from start of surgery to end of surgery, in an average of 2 hours)
Score of Mini-mental State Examination at 3 days after surgery(at 72h after the end of surgery)
visual analog scale of pain at 1 day after surgery(at 24h after the end of surgery)
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)
visual analog scale of pain at 3 days after surgery(at 72h after the end of surgery)
Rankin's score at 3 days after surgery(at 72h after the end of surgery)
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)
duration of postoperative in-hospital stay(from end of surgery to discharge from hospital, in an average of 7 days)
Quality of recovery score at 3 days after surgery(at 72h after the end of surgery)