De effecten van een rechter paravertebraal blok op de werking van het hart bij patiënten met pulmonale hypertentie die minimaal invasieve mitralisklepchirugie ondergaan.
- Conditions
- patients with pulmonary hypertension scheduled for elective minimally invasive mitral valve surgery using heartport technique.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-002000-14-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- patient scheduled for minimal invasive mitral valve surgery via right thoracotomy
- ASA II - IV
- chronic pulmonary hypertensio (systolic PAP >50 mmHg)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
- previous cardiac surgery
-contra-indication for TEE
- contra-indication for paravertebral block (allergies to local anesthetics, local infection, coagulation disorder, systemic inflammation,...)
- Tricupid insufficiency > 1/4
- patient refusal
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: a right paravertebral block does not influence the baseline myocardial performance of both the right and left ventricle in patients with chronically increase right ventricular afterload.;Secondary Objective: A right paravertebral block inhibits the positive inotropic response of the right ventricular to an acute increase in right ventricular afterload;Primary end point(s): Right ventricular function;Timepoint(s) of evaluation of this end point: after insertion of the paravertebral catheter<br>after onset of unilateral sympathetic blockade<br>after 20 min of single lung ventilation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): no secondary endpoint;Timepoint(s) of evaluation of this end point: not applicable