The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Changes in QTc, Tp-e interval during deliberate hypotension
研究概览
简要总结
Deliberate hypotension is defined as lowering the systolic blood pressure to 80-90mmHg, or the mean blood pressure to 50-65mmHg. This technique is usually employed for operations that have a high risk of intraoperative hemorrhage, such as orthognathic surgery. Several different regimens are used to lower the patient's blood pressure, such as vasodilators, autonomic nervous system inhibitors, opioids and inhalation anesthetics. However, the effects that these agents have on the QTc and Tp-e intervals during deliberate hypotension is not known. Virtually every kind of anesthetic is reported to have some effect on the QTc and Tp-e intervals. Because orthognathic surgery usually takes 3-4 hours to complete, the amount of anesthetics and drugs used to maintain low blood pressure is not small. Therefore, the effect that these agents may have on the QTc and Tp-e intervals may not be negligible. The investigators of the present study found that the high dose of commonly used hypotensive agents tend to prolong these variabilities to some extent. This study will be able to provide insight as to which hypotensive anesthesia regimen has the least effect on the QTc and Tp-e intervals, and therefore will be helpful in minimizing cardiovascular risks of deliberate hypotensive anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •ASA class 1
- •Adults over the age of 20
- •Patients requiring deliberate hypotensive anesthesia for orthognathic surgery
排除标准
- •Patient refusal
- •Patients with arrhythmia
- •Patients with cardiac anomalies or past history of cardiac surgery
- •Patients with abnormal electrolyte levels
- •Patients taking medications that are known to prolong QT intervals
- •Patients with QTc intervals greater than 440ms
- •Illiterate patients
研究组 & 干预措施
sevoflurane-remifentanil (group R)
Continuous infusion of remifentanil at 0.05 ~ 2 mcg/kg/min with sevoflurane concentration of 1 MAC
干预措施: Group R (Drug)
sevoflurane-nicardipine (group N)
Continuous infusion of nicardipine at 1 ~ 7 mcg/kg/min with sevoflurane concentration of 1 MAC
干预措施: Group N (Drug)
sevoflurane-dexmedetomidine (group D)
Continuous infusion of dexmedetomidine at 0.2 ~ 1.0 mcg/kg/hr with sevoflurane concentration of 1 MAC
干预措施: Group D (Drug)
结局指标
主要结局
Changes in QTc, Tp-e interval during deliberate hypotension
时间窗: Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery
次要结局
- Changes in Tp-e interval during deliberate hypotension(Before induction of anesthesia (T1), 10 minutes after induction of anesthesia (T2), 30 minutes after target blood pressure is reached (T3), every 60 minutes after from the end of surgery)
