The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction in Patients Undergoing TAVR Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
研究概览
简要总结
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui. The changes in blood pressure during the anesthesia induction period were compared between the high-frequency group and the low-frequency group.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patients is 60 years or older;
- •Patients who are scheduled to undergo TAVR surgery under general anesthesia;
排除标准
- •Body mass index less than 18 kg/m2 or greater than 30 kg/m2;
- •Hemodynamic instability (severe arrhythmia, decompensated heart failure);
- •Hypotension after admission requiring intervention with vasoactive drugs;
- •Severe liver or kidney dysfunction;
- •Those who are contraindicated for electrical stimulation, including those with local skin damage, infection, or having implanted electrophysiological devices in the body.
研究组 & 干预措施
High-frequency
The electrical stimulation is provided at a frequency of 100Hz
干预措施: electrical acupoint stimulation (Other)
Low-frequency
The electrical stimulation is provided at a frequency of 2Hz
干预措施: electrical acupoint stimulation (Other)
结局指标
主要结局
The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.
时间窗: from start of induction to 15 minutes after induction
The area under the curve (AUC) below baseline mean arterial pressure (MAP) is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at the i-th minute (i = 1…15), and ΔX is the time interval between two measurements.
次要结局
- Incidence of hypotension during the induction period(from start of induction to 15 minutes after induction)
- The dosage of vasoactive drugs(from start of induction to 15 minutes after induction)
- The incidence of major complications (cardiovascular adverse events, acute kidney injury, delirium)(from end of surgery to discharge from the hospital, at an average of 5 days)
- Length of hospital stay(from end of surgery to discharge from the hospital, at an average of 5 days)
- The rate of patients admitted to the intensive care unit (ICU) after surgery(from end of surgery to discharge from the hospital, at an average of 5 days)
- The rate of patients achieving the best recovery after surgery (discharged within 5 days after surgery, without major complications, no incision infection, no readmission, and survive within 30 days after surgery)(from end of surgery to 30 days after surgery)
- The score of the discharge quality assessment scale(at discharge from the hospital, at an average of 5 days after surgery)
研究者
Zhihong LU
Associate Professor
Air Force Military Medical University, China