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the Effect of Tracleer on Tourniquet-associated Hypertension

Primary Purpose

Tourniquets, Hypertension, Bosentan

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tracleer 125Mg Tablet
Placebo
Sponsored by
Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tourniquets

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tracleer (or Bosentan)

Placebo

Arm Description

Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery

Placebo was administered orally at two hours before surgery and six hours after surgery

Outcomes

Primary Outcome Measures

Maximum rate of change in systolic blood pressure (MR)
During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure

Secondary Outcome Measures

the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine
test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point
visual analog scale
assess the efficacy of analgesia using visual analog scale (VAS)

Full Information

First Posted
July 20, 2017
Last Updated
July 22, 2017
Sponsor
Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03229694
Brief Title
the Effect of Tracleer on Tourniquet-associated Hypertension
Official Title
Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourniquets, Hypertension, Bosentan

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tracleer (or Bosentan)
Arm Type
Experimental
Arm Description
Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo was administered orally at two hours before surgery and six hours after surgery
Intervention Type
Drug
Intervention Name(s)
Tracleer 125Mg Tablet
Other Intervention Name(s)
Bosentan, endothelin receptor antagonist
Intervention Description
Tracleer was administered orally at two hours before surgery and six hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was administered orally at two hour before surgery and six hours after surgery.
Primary Outcome Measure Information:
Title
Maximum rate of change in systolic blood pressure (MR)
Description
During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine
Description
test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point
Time Frame
baseline and intraoperative
Title
visual analog scale
Description
assess the efficacy of analgesia using visual analog scale (VAS)
Time Frame
24 hrs after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Cao, professor
Phone
+86-516-85802291
Email
xyfyll2297@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Liu, doctor
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Cao, doctor
Phone
+86-516-85802291
Email
xyfyll2297@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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the Effect of Tracleer on Tourniquet-associated Hypertension

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