the Effect of Tracleer on Tourniquet-associated Hypertension

NCT03229694 — Phase 4, Unknown, 80 participants, Xuzhou Medical University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03229694
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	80 (Estimated)
Sponsor	Xuzhou Medical University (Other)
Conditions	Tourniquets, Hypertension, Bosentan
Interventions	Tracleer 125Mg Tablet, Placebo (Drug)
Dates	start 2017-08-01 (estimated), primary completion 2018-04-01 (estimated), completion 2018-05-01 (estimated), first posted 2017-07-25, last updated 2017-07-25
Locations	1 site in China

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Tracleer (or Bosentan)	Experimental	Drug: Tracleer 125Mg Tablet	Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Placebo	Placebo comparator	Drug: Placebo	Placebo was administered orally at two hours before surgery and six hours after surgery

Tracleer 125Mg Tablet (Drug), also known as Bosentan, endothelin receptor antagonist: Tracleer was administered orally at two hours before surgery and six hours after surgery.
Placebo (Drug): Placebo was administered orally at two hour before surgery and six hours after surgery.

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
The Affiliated Hospital of Xuzhou Medical University	Xuzhou, Jiangsu	China

+Investigators

Su Liu, doctor, Principal investigator, The Affiliated Hospital of Xuzhou Medical University