Clinical trial NCT02979028: Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty
Official title: The Protective Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Aged Patients Undergoing Lower Extremity Arthroplasty: A Single-Center, Double-Blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Joint Replacement
Keywords: TEAS
complication
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a single center, randomized, double-blinded, controlled clinical trial. The purpose of this study is to to determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative complications in patients undergoing artificial joint replacement surgery.

Detailed description: The complications from patients accepted artificial joint replacement surgery will directly or indirectly affect the prognosis of the patients, resulting in patients with delayed recovery and increase the hospitalization time and cost. Serious complications can lead to patients deaths during perioperative period. It has been proved that the electroacupuncture application during perioperative period can reduce the dosage of anesthetic drugs, and has a good effect on the protection of the heart and brain. At the same time, the electroacupuncture can also regulate the body's immune function, reduce allergy, reduce postoperative pain and so on.Compared with acupuncture, transcutaneous electric acupoint stimulation (TEAS) is a noninvasive technique that has similar effects to acupuncture. The investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after artificial joint replacement surgery.

Eligibility criteria: Inclusion Criteria:

1. ASAⅡ-Ⅲ,elective operation patients
2. No other severe complications history
3. Able to give informed consent

Exclusion Criteria:

1. Having severe comorbidity resulting in estimated life expectancy \<1 year.
2. Infection at the electroacupuncture site.
3. Suffered from neurologic disorder or impaired mental state
4. Participate in the other clinical trial 3 months before the enrollment
5. No suitable to participate in this experiment

Primary outcomes:
measure: The incidence of postoperative complications
timeFrame: within 30 days after operation
Secondary outcomes:
measure: length of postoperative hospital stay
timeFrame: an expected average of 1 week
measure: Quality of life during 30 days after surgery
timeFrame: One month
measure: ICU transfer rate after operation
timeFrame: One month
Other outcomes:
Locations:
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: Zheng Guo
role: STUDY_CHAIR
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