PROPOFOL for Valvular heart disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years."}
• {"criterion_text":"- 2. Elective surgery cardiac surgery with double valve pump."}
• {"criterion_text":"- 3. Use of Nido cardioplegia, common in this type of patient"}

Exclusion criteria

• {"criterion_text":"- 1. History of adverse reaction to sevoflurane or propofol."}
• {"criterion_text":"- 2. Severe disease of any organ (lung, liver, kidney), diagnosed preoperatively."}
• {"criterion_text":"- 3. Combined surgery (e.g. coronary or carotid surgery)."}
• {"criterion_text":"- 4. Patients in a situation of hemodynamic instability."}
• {"criterion_text":"- 5. Heart failure or need to use inotropic or vasoactive drugs prior to the intervention."}
• {"criterion_text":"- 6. Treatment with oral antidiabetics not suspended at least 48 hours before."}
• {"criterion_text":"- 7. Treatment with euphylline/theophylline prior to the intervention."}
• {"criterion_text":"- 8. Inability to grant informed consent."}
• {"criterion_text":"- 9. Pregnancy or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- Sex","definition_or_measurement_approach":""}
• {"endpoint_text":"- Age","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cardiac index","definition_or_measurement_approach":"Measurement of the cardiac index intraoperatively and immediately postoperatively."}
• {"endpoint_text":"- Creatinine","definition_or_measurement_approach":""}
• {"endpoint_text":"- N-GAL","definition_or_measurement_approach":""}
• {"endpoint_text":"- Stroke Volume index","definition_or_measurement_approach":""}
• {"endpoint_text":"- Heart rate, beats / min","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mean arterial pressure","definition_or_measurement_approach":""}
• {"endpoint_text":"- Right ventricular end-diastolic pressure","definition_or_measurement_approach":""}
• {"endpoint_text":"- Troponin I","definition_or_measurement_approach":"Measurement of troponin I levels."}
• {"endpoint_text":"- NT-ProBNP","definition_or_measurement_approach":"Measurement of NT-ProBNP levels."}
• {"endpoint_text":"- Pre/postconditioning enzymes","definition_or_measurement_approach":""}
• {"endpoint_text":"- Renal dysfunction","definition_or_measurement_approach":""}
• {"endpoint_text":"- Inotropic support","definition_or_measurement_approach":"Recording of use of inotropes for low cardiac output syndrome."}
• {"endpoint_text":"- Days of ICU stay","definition_or_measurement_approach":""}
• {"endpoint_text":"- circRNA values","definition_or_measurement_approach":"Measurement of circRNA baseline expression and variation at 24 hours."}

Spain

Earliest CTIS Part Ii Submission Date

24-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

3

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain