the Effect of Tracleer on Tourniquet-associated Hypertension
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|ClinicalTrials.gov Identifier: NCT03229694|
Recruitment Status : Unknown
Verified July 2017 by Su Liu, Xuzhou Medical University.
Recruitment status was: Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Tourniquets Hypertension Bosentan||Drug: Tracleer 125Mg Tablet Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty|
|Estimated Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||April 1, 2018|
|Estimated Study Completion Date :||May 1, 2018|
Experimental: Tracleer (or Bosentan)
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Drug: Tracleer 125Mg Tablet
Tracleer was administered orally at two hours before surgery and six hours after surgery.
Placebo Comparator: Placebo
Placebo was administered orally at two hours before surgery and six hours after surgery
Placebo was administered orally at two hour before surgery and six hours after surgery.
- 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
- the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine [ Time Frame: baseline and intraoperative ]test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point
- visual analog scale [ Time Frame: 24 hrs after surgery ]assess the efficacy of analgesia using visual analog scale (VAS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229694
|Contact: Jiang Cao, firstname.lastname@example.org|
|The Affiliated Hospital of Xuzhou Medical University|
|Xuzhou, Jiangsu, China|
|Contact: Jiang Cao, doctor +86-516-85802291 email@example.com|
|Principal Investigator:||Su Liu, doctor||Affiliated hospital of Xuzhou medical university|