Procedural Sedation

This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and/or colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and/or colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music. The main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.

The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain. Procedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen. SED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression). In this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced. The study complies with MDR 2017/745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB/2026/0307). Expected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.

This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. The main question it aims to answer is: • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke? GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased. Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke. Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.

This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate \< 8).