Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
Overview
- Phase
- Phase 4
- Sponsor
- Xuzhou Medical University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Maximum rate of change in systolic blood pressure (MR)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Leukocyte higher than normal value
- •Pneumonia, asthma, chronic obstructive pulmonary disease
Arms & Interventions
Tracleer (or Bosentan)
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Intervention: Tracleer 125Mg Tablet (Drug)
Placebo
Placebo was administered orally at two hours before surgery and six hours after surgery
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Maximum rate of change in systolic blood pressure (MR)
Time Frame: 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
Secondary Outcomes
- visual analog scale(24 hrs after surgery)
- the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine(baseline and intraoperative)
Investigators
Su Liu
Associtate professor
Xuzhou Medical University