the Effect of Tracleer on Tourniquet-associated Hypertension

NCT03229694 | Unknown Phase 4 FDA Drug

• 1 other identifier: XYFY-2017-068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourniquets; Hypertension; Bosentan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine

  baseline and intraoperative

• visual analog scale

  24 hrs after surgery

Study Arms (2)

Tracleer (or Bosentan)

EXPERIMENTAL

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

Drug: Tracleer 125Mg Tablet

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tracleer 125Mg Tablet DRUG

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

Also known as: Bosentan, endothelin receptor antagonist

Tracleer (or Bosentan)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent selected total knee arthroplasty under general anesthesia
• ASA II-III
• \~65 years old
• Signed informed consent voluntarily

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Bosentan; Tablets; Endothelin Receptor Antagonists

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Su Liu, doctor

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Cao, professor

CONTACT

+86-516-85802291; xyfyll2297@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associtate professor

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 25, 2017
• Study Start: August 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

CN (1)