Effects of TENS on Myocardial Protection in Patients Undergoing AVR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Infarct size after TENS
研究概览
简要总结
Patients undergoing aortic valve replacement are randomized to receive TENS (transcutaneous electrical nerve stimulation) or sham stimulation at one arm for 30 min under various anesthetic conditions: no anesthesia (preanesthesia), sevoflurane or propofol anesthesia. Cardioprotective effects of TENS are compared through Langendorff rat heart perfusion system using plasma dialysate from patients.
详细描述
Patients undergoing aortic valve replacement are randomized to one of six groups: preanesthesia-TENS (transcutaneous electrical nerve stimulation), preanesthesia-sham, sevoflurane-TENS, sevoflurane-sham, propofol-TENS, propofol-sham. Patients receive TENS or sham stimulation (without electrical pulse generation) at one arm for 30 min under no anesthesia (preanesthesia) or sevoflurane or propofol anesthesia.
In all patients, blood samples are obtained before and after TENS or sham procedure to make plasma dialysate to perfuse rat hearts subjected to ischemia-reperfusion injury through Langendorff system.
Cardioprotective effects are determined by comparing infarct sizes of rat hearts perfused with human plasma dialysate, which reflects cardioprotective effects of TENS in human subjects. By comparing infarct size differences, the myocardial protective effects of TENS in various anesthetic conditions can be determined in human subjects undergoing aortic valve replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing aortic valve replacement
排除标准
- •co-medications: metformin, nitroglycerine, nicorandil
- •discomfort at TENS or loss of intact skin
- •uncontrolled hypertension or diabetes mellitus
- •severely impaired renal or hepatic function
- •peripheral vasculopathy or neuropathy
- •did not consent to participate
- •pregnancy
研究组 & 干预措施
preanesthesia-TENS
Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.
干预措施: TENS (transcutaneous electrical nerve stimulation) (Procedure)
preanesthesia-sham
Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.
干预措施: sham intervention (Procedure)
sevoflurane-TENS
Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.
干预措施: TENS (transcutaneous electrical nerve stimulation) (Procedure)
sevoflurane-sham
Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.
干预措施: sham intervention (Procedure)
propofol-TENS
Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.
干预措施: TENS (transcutaneous electrical nerve stimulation) (Procedure)
propofol-sham
Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.
干预措施: sham intervention (Procedure)
结局指标
主要结局
Infarct size after TENS
时间窗: 30 minutes
Infarct size of rat hearts perfused with dialysate after TENS compared with sham
次要结局
未报告次要终点
研究者
Yunseok Jeon
Professor
Seoul National University Hospital