Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maximum rate of change in systolic blood pressure (MR)
研究概览
简要总结
Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. Thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery.
Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present trial, the investigators are going to investigate the effect of Tracleer on tourniquet-associated hypertension during total knee arthroplasty.
详细描述
At present study, the investigators will use endothelin receptor antagonist, Tracleer (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The purpose of this study is to find a new therapy to prevent and treat tourniquet-associated hypertension.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent selected total knee arthroplasty under general anesthesia
- •ASA II-III
- •18~65 years old
- •Signed informed consent voluntarily
排除标准
- •Do not apply tourniquet during the surgery
- •Patients underwent emergency surgery
- •Having applied tourniquet in last three months
- •Patients underwent bilateral total knee arthroplasty
- •Dysfunction of liver or kidney
- •Anemia (Hb <90 g/L)
- •Serious myocardial disease (eg. coronary heart disease, heart failure, severe arrhythmia)
- •Coagulation disorder
- •Leukocyte higher than normal value
- •Pneumonia, asthma, chronic obstructive pulmonary disease
- •Hypotension before surgery (systolic pressure < 90 mmHg)
- •Pregnant woman or puerpera
- •Having being enrolled in other clinical trial in last 3 months
研究组 & 干预措施
Tracleer (or Bosentan)
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
干预措施: Tracleer 125Mg Tablet (Drug)
Placebo
Placebo was administered orally at two hours before surgery and six hours after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum rate of change in systolic blood pressure (MR)
时间窗: 24 hours after surgery
During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure
次要结局
- visual analog scale(24 hrs after surgery)
- the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine(baseline and intraoperative)
研究者
Su Liu
Associtate professor
Xuzhou Medical University