Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
Condition: Stroke; Brain Injuries
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture
      pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized
      and controlled clinical trial. In addition, to investigate the role of inflammatory responses
      in the precess of the protection.
    

Detailed description: 
      Heart valve replacement surgery has been proved to be an effective method in treating both
      regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass
      (CPB) and operation related cerebral injury is associated with worse patient morbidity and
      mortality after elective valve replacement surgery. Recently, Electroacupuncture (EA)
      pretreatment was proved to produced cerebral protective effects by mimicking ischemic
      preconditioning in animal models. However, the evidence that EA pretreatment can improve the
      clinical outcomes such as mortality and morbidity, is still lacking. The investigators
      perform a randomized controlled study to evaluate that EA pretreatment can improve the
      outcomes of cardiac surgery.

      Purpose:

      The purpose of this study is to examine if EA pretreatment can decrease the mortality and
      postoperative cerebrovascular complications in patients undergoing cardiac surgery. The
      effect will be assessed by mortality, scores of neurological defect, post operative cognitive
      dysfunction and stroke.

      Methods:

      Study patients will be randomized to cardiac surgery with EA pretreatment or conventional
      cardiac surgery in the Department of cardiovascular surgery, Xijing Hospital. EA pretreatment
      is performed at Baihui acupoint 30 min per day 5 consecutive days before the heart valve
      replacement surgery．Primary study outcome is cerebrovascular complications within 6
      postoperative months. Secondary outcomes include the S-100B and NSE blood level measured
      during the first 72 hours of surgery follow-up, the several cytokines, including TNF-a, IL-8,
      IL-6, IL-10 and HMGB-1 blood level measured during the first 7 days of surgery follow-up, all
      cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter, the length
      of intensive care unit (ICU) stay and length of postoperative hospital stay.
    

Intervention name(s): non electroacupuncture stimulation; Electroacupuncture pretreatment
Intervention type(s): Procedure; Procedure
Intervention description(s): The same procedure as electroacupuncture except stimulation; According to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery．
Other intervention name(s): Acupuncture; preconditioning; electric stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: brain protection; cardiac surgery; heart valve replacement; electroacupuncture; pretreatment; preconditioning; Thoracic Surgery