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: Unknown
• Conditions: Hypertension; Tourniquets; Bosentan
• Intervention / Treatment: Drug: Tracleer 125Mg Tablet; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and intraoperative
visual analog scale	assess the efficacy of analgesia using visual analog scale (VAS)	24 hrs after surgery

Collaborators and Investigators

• Sponsor: Xuzhou Medical University
• Investigators: Principal Investigator: Su Liu, doctor, The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 22, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 22, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Bosentan; Endothelin Receptor Antagonists
• Other Study ID Numbers: XYFY-2017-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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