NCT03229694

the Effect of Tracleer on Tourniquet-associated Hypertension

Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tourniquets
• Hypertension
• Bosentan

Interventions

Type	Name	Description
DRUG	Tracleer 125Mg Tablet	Tracleer was administered orally at two hours before surgery and six hours after surgery.
DRUG	Placebo	Placebo was administered orally at two hour before surgery and six hours after surgery.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-04-01
• Completion: 2018-05-01
• First posted: 2017-07-25
• Last updated: 2017-07-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study