the Effect of Tracleer on Tourniquet-associated Hypertension

Phase 4

• Conditions: Tourniquets; Hypertension; Bosentan
• Interventions: Drug: Tracleer 125Mg Tablet; Drug: Placebo

• Registration Number: NCT03229694
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-22
• Last Update Submitted: 2017-07-22
• Study First Posted: 2017-07-25
• Last Update Posted: 2017-07-25
• Study Start: 2017-08-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tracleer (or Bosentan)	Tracleer 125Mg Tablet	Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery
Placebo	Placebo	Placebo was administered orally at two hours before surgery and six hours after surgery

Primary Outcome Measures

Name	Time	Method
Maximum rate of change in systolic blood pressure (MR)	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

Name	Time	Method
visual analog scale	24 hrs after surgery	assess the efficacy of analgesia using visual analog scale (VAS)
the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine	baseline and intraoperative	test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China