KETAMINE HYDROCHLORIDE for Aortic stenosis

Inclusion criteria

• {"criterion_text":"-Patients undergoing TAVR"}
• {"criterion_text":"-Age between 18 and 95 years."}
• {"criterion_text":"-Patient's agreement to participate in the protocol and to sign the informed consent form."}

Exclusion criteria

• {"criterion_text":"-Lack of informed consent"}
• {"criterion_text":"-Acute cerebrovascular conditions;"}
• {"criterion_text":"-Advanced heart failure."}
• {"criterion_text":"-allergies to sedative medications used or to any of the excipients"}
• {"criterion_text":"-presence of preoperative delirium"}
• {"criterion_text":"-Patients with psychiatric disorders on pharmacological therapy;"}
• {"criterion_text":"-Participation in a clinical study where an experimental drug has been administered within 30 days of screening or within the 5 half-lives of the investigational drug (whichever period is longer)"}
• {"criterion_text":"-Women of potentially childbearing age (potentially childbearing age: any woman who has had her first menstruation until the post-menopausal period; postmenopausal woman: woman at least 45 years old who has not had menstrual periods for at least 12 months);"}
• {"criterion_text":"-Concomitant procedures other than TAVR (e.g., Percutaneous Coronary Intervention);"}
• {"criterion_text":"-Advanced 2nd or 3rd degree atrioventricular block in patients without a pacemaker;"}
• {"criterion_text":"-Uncontrolled hypotension"}

Primary endpoints

• {"endpoint_text":"-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.","definition_or_measurement_approach":"Defined as pH<7.35 and an increase in PaCO2 compared to baseline, measured through serial arterial blood gas analysis during the procedure."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Assessed using the CAM-ICU within the first 24 hours following the end of the procedure."}

Secondary endpoints

• {"endpoint_text":"-The assessment of sedation effectiveness includes: -\tTime to achieve the desired sedation target (from the start of sedation to reaching a Richmond Agitation Sedation Scale of -2/-3). -\tTime to meet discharge criteria from the operating room (from sedation cessation to achieving an Aldrete's scoring system score >9). -\tIncidence of agitation episodes (RASS > +1). -\tIntraprocedural need to deviate from the established protocol beyond the therapeutic ranges indicated.","definition_or_measurement_approach":"Measures include time to achieve RASS -2/-3, time from sedation cessation to Aldrete score >9, incidence of agitation episodes (RASS > +1), and intraprocedural deviations from protocol."}
• {"endpoint_text":"-The assessment of the incidence of intra-procedural adverse events includes: -\tIncidence 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). -\tIncidence of hemodynamic events (hypotension, bradycardia, need for vasopressor support).","definition_or_measurement_approach":"Incidence of defined respiratory events and hemodynamic events during procedure; respiratory acidosis defined as pH<7.35 with increased PaCO2 compared to baseline."}
• {"endpoint_text":"-The evaluation of post-operative adverse events includes: -\tTotal duration of hospitalization. -\tIncidence of post-operative cognitive decline (changes in Mini Mental State postoperative compared to baseline).","definition_or_measurement_approach":"Post-operative outcomes include total hospital stay duration and change in Mini Mental State exam postoperative vs baseline."}

Italy

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

01-07-2024

Processing Time Days

34

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Ovest Milanese

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy