- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03229694
the Effect of Tracleer on Tourniquet-associated Hypertension
Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jiang Cao, professor
- Phone Number: +86-516-85802291
- Email: xyfyll2297@163.com
Study Locations
-
-
Jiangsu
-
Xuzhou, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical University
-
Contact:
- Jiang Cao, doctor
- Phone Number: +86-516-85802291
- Email: xyfyll2297@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tracleer (or Bosentan)
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
|
Tracleer was administered orally at two hours before surgery and six hours after surgery.
Other Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and intraoperative
|
visual analog scale
Time Frame: 24 hrs after surgery
|
assess the efficacy of analgesia using visual analog scale (VAS)
|
24 hrs after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Su Liu, doctor, The Affiliated Hospital of Xuzhou Medical University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XYFY-2017-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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