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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tracleer (or Bosentan) | Experimental | Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery |
|
| Placebo | Placebo Comparator | Placebo was administered orally at two hours before surgery and six hours after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tracleer 125Mg Tablet | Drug | Tracleer was administered orally at two hours before surgery and six hours after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum rate of change in systolic blood pressure (MR) | During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine | test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point | baseline and intraoperative |
| visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Cao, professor | Contact | +86-516-85802291 | xyfyll2297@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Liu, doctor | The Affiliated Hospital of Xuzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D013607 | Tablets |
| D065128 | Endothelin Receptor Antagonists |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo was administered orally at two hour before surgery and six hours after surgery. |
|
assess the efficacy of analgesia using visual analog scale (VAS)
| 24 hrs after surgery |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |