跳至主要内容
临床试验/NCT01634594
NCT01634594已完成4 期

The Effect of Deliberate Hypotension on QTc, Tp-e Intervals and Heart Rate Variability

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

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

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)

Experimental

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)

Active Comparator

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)

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验