the Effect of Tracleer on Tourniquet-associated Hypertension

Hypertension Clinical Trial

Official title:

Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03229694
• Other study ID #: XYFY-2017-068
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 20, 2017
• Last updated: July 22, 2017
• Start date: August 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2017
• Source: Xuzhou Medical University
• Contact: Jiang Cao, professor
• Phone: +86-516-85802291
• Email: xyfyll2297[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bosentan
• Hypertension
• Tourniquets

Intervention

Drug:
• Tracleer 125Mg Tablet
Tracleer was administered orally at two hours before surgery and six hours after surgery.
• Placebo
Placebo was administered orally at two hour before surgery and six hours after surgery.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	visual analog scale	assess the efficacy of analgesia using visual analog scale (VAS)	24 hrs after surgery