Tourniquets, Hypertension, Bosentan
Conditions
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.
Interventions
Tracleer was administered orally at two hours before surgery and six hours after surgery.
DRUGPlacebo
Placebo was administered orally at two hour before surgery and six hours after surgery.
Sponsors
Xuzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum rate of change in systolic blood pressure (MR) | 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
| Measure | Time frame | Description |
|---|---|---|
| the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine | baseline and intraoperative | test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point |
| visual analog scale | 24 hrs after surgery | assess the efficacy of analgesia using visual analog scale (VAS) |
Countries
China
Contacts
Primary ContactJiang Cao, professor
Outcome results
None listed