patients with aortic stenosis underwent transcatheter aortic valve replacement
Conditions
Brief summary
Incidence of respiratory acidosis: Defined as pH<7.35 and an increase in PaCO2 compared to baseline, measured through serial arterial blood gas analysis during the procedure., Incidence of emergence delirium: Assessed through the administration of the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) within the first 24 hours following the end of the procedure.
Detailed description
The assessment of sedation effectiveness includes: - Time to achieve the desired sedation target (from the start of sedation to reaching a Richmond Agitation Sedation Scale of -2/-3). - Time to meet discharge criteria from the operating room (from sedation cessation to achieving an Aldrete's scoring system score >9). - Incidence of agitation episodes (RASS > +1). - Intraprocedural need to deviate from the established protocol beyond the therapeutic ranges indicated., The assessment of the incidence of intra-procedural adverse events includes: - Incidence of respiratory events (desaturation, need for supplemental oxygen, loss of respiratory drive, need for mask ventilation, respiratory acidosis with pH<7.35 and an increase in PaCO2 compared to baseline). - Incidence of hemodynamic events (hypotension, bradycardia, need for vasopressor support)., The evaluation of post-operative adverse events includes: - Total duration of hospitalization. - Incidence of post-operative cognitive decline (changes in Mini Mental State postoperative compared to baseline).
Interventions
DRUGRemifentanil Mylan 1 mg
DRUGDexmedetomidina Ever Pharma 100 microgrammi/ml concentrato per soluzione per infusione
DRUGPropofol Kabi 10 mg/ml emulsione iniettabile o per infusione
Sponsors
Azienda Socio Sanitaria Territoriale Ovest Milanese
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of respiratory acidosis: Defined as pH<7.35 and an increase in PaCO2 compared to baseline, measured through serial arterial blood gas analysis during the procedure., Incidence of emergence delirium: Assessed through the administration of the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) within the first 24 hours following the end of the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of sedation effectiveness includes: - Time to achieve the desired sedation target (from the start of sedation to reaching a Richmond Agitation Sedation Scale of -2/-3). - Time to meet discharge criteria from the operating room (from sedation cessation to achieving an Aldrete's scoring system score >9). - Incidence of agitation episodes (RASS > +1). - Intraprocedural need to deviate from the established protocol beyond the therapeutic ranges indicated., The assessment of the incidence of intra-procedural adverse events includes: - Incidence of respiratory events (desaturation, need for supplemental oxygen, loss of respiratory drive, need for mask ventilation, respiratory acidosis with pH<7.35 and an increase in PaCO2 compared to baseline). - Incidence of hemodynamic events (hypotension, bradycardia, need for vasopressor support)., The evaluation of post-operative adverse events includes: - Total duration of hospitalization. - Incidence of post-operative cognitive decline | — |
Countries
Italy
Outcome results
None listed