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the Effect of Tracleer on Tourniquet-associated Hypertension

X

Xuzhou Medical University

Status and phase

Unknown
Phase 4

Conditions

Bosentan
Hypertension
Tourniquets

Treatments

Drug: Tracleer 125Mg Tablet
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03229694
XYFY-2017-068

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients underwent selected total knee arthroplasty under general anesthesia
  • ASA II-III
  • 18~65 years old
  • Signed informed consent voluntarily

Exclusion criteria

  • 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
  • Diabetic
  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups, including a placebo group

Tracleer (or Bosentan)
Experimental group
Description:
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Treatment:
Drug: Tracleer 125Mg Tablet
Placebo
Placebo Comparator group
Description:
Placebo was administered orally at two hours before surgery and six hours after surgery
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Jiang Cao, professor

Data sourced from clinicaltrials.gov

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