SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation

Inclusion Criteria: * Age ≥18 years * ASA physical status I-III * Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure * Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system * Administration of sedative and analgesic drugs via a peripheral venous line * Ability to understand the study information and provide written informed consent Exclusion Criteria: * Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders). * Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response * ASA physical status IV, V or VI * Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring * Requirement for central venous access for drug administration * Sedation performed outside the endoscopy unit (e.g., intensive care, emergency department) * Inability to understand study information, provide consent or cooperate with clinical assessments due to language barrier or cognitive impairment