Radical Cystectomy Clinical Trial
Official title:
Hemodynamic Effects of Pressure-regulated Volume Controlled Versus Volume-controlled Ventilation Mode in Patients With Diastolic Dysfunction Undergoing Radical Cystectomy- A Cross Over Randomized Study
Verified date | March 2024 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diastolic function is a combination of ventricular chamber compliance, active myofilament relaxation, and elastic recoil of systolic potential energy. Diastole is classically divided into four stages-isovolumetric relaxation, early rapid filling, late slow filling, and atrial contraction. Isovolumetric relaxation refers to the rapid decrease in LV pressure with little or no change in volume and ends with the opening of the mitral valve and early LV filling. These early phases, sometimes referred to as LV suction, are characterized by a rapid decline in LV intracavity pressure and require energy in the form of ATP to pump cytosolic calcium back into the sarcoplasmic reticulum and enable uncoupling of actin and myosin. Filling later in diastole is more dependent on ventricular compliance. Up to investigator knowledge, the effect of mechanical ventilation on patient hemodynamics is still unclear especially in patients with diastolic dysfunction. The optimal ventilation mode for anesthesia of patient with diastolic dysfunction remains a subject of debate. The primary outcome of this study is to investigate whether the pressure regulated volume-controlled mode (PRVC) in comparison with the volume-controlled mode in patients with diastolic dysfunction is associated with better hemodynamic alterations and different vasopressors support during anesthesia for radical cystectomy.
Status | Completed |
Enrollment | 76 |
Est. completion date | February 10, 2024 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. adult patients with diagnosed diastolic dysfunction. 2. long term controlled hypertension. 3. Long term controlled diabetes mellitus. 4. Controlled atrial fibrillation. 5. Aged patients above 60 years Exclusion Criteria: 1. Patients younger than 18 years. 2. Patients with body mass index (BMI) ? 25 and ?35 wts 3. Major cardiovascular problems with ejection fraction ? 40 %. 4. Any implanted mechanical cardiac device |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and nephrology center | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of noradrenaline use during anesthesia. | The number of patients that will need noradrenaline as vasopressor during anesthesia with either modes of ventilation to maintain hemodynamic stability. | perioperative time for 24 hours | |
Primary | The incidence of Cardiac output changes during anesthesia . | The number of participants associated with cardiac output and stroke volume drop during anesthesia with each mode of ventilation . | perioperative time for 24 hours | |
Secondary | The incidence of any other inotropic administration during perioperative time | The number of participants and total dose of other inotropic administration like dobutamine or dopamine during perioperative time to ensure hemodynamic stability. | perioperative time for 24 hours | |
Secondary | The incidence of difficult weaning from mechanical ventilation . - | The number of participants associated with difficult weaning from mechanical ventilation that may be enhanced by diastolic dysfunction in both groups. | End of surgery. | |
Secondary | Incidence of associated myocardial ischemia, infarction, arrhythmia or cardiogenic pulmonary edema. | Decrease incidence of associated predefined Myocardial ischemia, infarction, arrhythmia, cardiogenic pulmonary edema. | perioperative time for 24 hours. | |
Secondary | The incidence of postoperative hypotension . | The number of participants that will presented with postoperative hypotension with mean arterial blood pressure less than 65 mmHg in both groups | 24-hours postoperative | |
Secondary | The incidence postoperative mortality. | The incidence of postoperative mortality of anesthesia related complications. | 7-days postoperative |
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