Prospective comparative randomized study of procedural sedation during TAVR (Transcatheter Aortic Valve Replacement)

Phase 1

Conditions: patients with aortic stenosis underwent transcatheter aortic valve replacement
Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2024-511018-18-00

Lead Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1

Inclusion Criteria

Patients undergoing TAVR, Age between 18 and 95 years., Patient's agreement to participate in the protocol and to sign the informed consent form.

Exclusion Criteria

Lack of informed consent, Acute cerebrovascular conditions;, Advanced heart failure., allergies to sedative medications used or to any of the excipients, presence of preoperative delirium, Patients with psychiatric disorders on pharmacological therapy;, 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), 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);, Concomitant procedures other than TAVR (e.g., Percutaneous Coronary Intervention);, Advanced 2nd or 3rd degree atrioventricular block in patients without a pacemaker;, Uncontrolled hypotension

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -Determine if there are differences in the incidence of intra-procedural respiratory acidosis.<br>-Determine if there are differences in the incidence of emergence delirium within the first 24 hours following the end of the procedure.;Secondary Objective: Assessment of sedation effectiveness., -Evaluation of the incidence of adverse events during and after the procedure;Primary end point(s): 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 Outcome Measures