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Trial record 48 of 228 for:    EDN1

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
Sponsor:
Information provided by (Responsible Party):
Su Liu, Xuzhou Medical University

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.


Condition or disease Intervention/treatment Phase
Tourniquets Hypertension Bosentan Drug: Tracleer 125Mg Tablet Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Arm Intervention/treatment
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.
Other Names:
  • Bosentan
  • endothelin receptor antagonist

Placebo Comparator: Placebo
Placebo was administered orally at two hours before surgery and six hours after surgery
Drug: Placebo
Placebo was administered orally at two hour before surgery and six hours after surgery.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. visual analog scale [ Time Frame: 24 hrs after surgery ]
    assess the efficacy of analgesia using visual analog scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jiang Cao, professor +86-516-85802291 xyfyll2297@163.com

Locations
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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Not yet recruiting
Xuzhou, Jiangsu, China
Contact: Jiang Cao, doctor    +86-516-85802291    xyfyll2297@163.com   
Sponsors and Collaborators
Xuzhou Medical University
Investigators
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Principal Investigator: Su Liu, doctor Affiliated hospital of Xuzhou medical university

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Responsible Party: Su Liu, Associtate professor, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03229694     History of Changes
Other Study ID Numbers: XYFY-2017-068
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Bosentan
Endothelin Receptor Antagonists
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action