the Effect of Tracleer on Tourniquet-associated Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tourniquets Hypertension Bosentan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tracleer (or Bosentan)

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

Group Type EXPERIMENTAL

Tracleer 125Mg Tablet

Intervention Type DRUG

Tracleer was administered orally at two hours before surgery and six hours after surgery.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tracleer 125Mg Tablet

Tracleer was administered orally at two hours before surgery and six hours after surgery.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Bosentan endothelin receptor antagonist

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No