[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monitored-anaesthesia-care\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monitored-anaesthesia-care":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100615893","phase-4-safety-exploration-and-evaluation-of-dexmedetomidine-hydrochloride-nasal-spray-for-pre-anesthesia-sedation-in-low-monitoring-settings-100615893",false,"NCT07298525","Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings","Inclusion Criteria:\n\n* be 18 years of age or older, including the age of 18; no gender limitation;\n* American Society of Anesthesiologists (ASA) grade I to III;\n* Require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure;\n* Provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly.\n\nExclusion Criteria:\n\n* Individuals with a known hypersensitivity to dexmedetomidine hydrochloride or any excipient; patients with a documented allergy to any tranquilizers, opioids, or other substances employed in the trial;\n* Individuals with airway hyperactivity, such as those suffering from chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea, who are determined by the researchers to have experienced or are experiencing safety concerns related to these conditions;\n* Patients with a history of nasal disorders, previous surgical procedures, or allergic reactions deemed clinically significant by the research team, which could significantly impact drug absorption (e.g., chronic nasal congestion, rhinorrhea, nosebleeds, and other symptoms, as well as anatomical or mucosal abnormalities in the nose that may affect drug uptake);\n* A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period;\n* patients with current psychiatric disorders (like schizophrenia or depression) or cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse;\n* A history of myocardial infarction or unstable angina pectoris within the past six months prior to the screening phase;\n* A heart rate or pulse rate of less than or equal to 50 beats per minute during the screening period, the presence of clinically significant heart functional abnormalities as determined by the investigators, or the presence of grade II or higher atrioventricular block (excluding patients with implanted pacemakers) along with other severe arrhythmias;\n* Patients with inadequately controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg during the screening period) or hypotension (systolic blood pressure ≤90 mmHg and\u002For diastolic blood pressure ≤ mmHg during the screening period);\n* Participants who have already engaged in other clinical trials and have taken the investigational drug within the three months preceding the screening period;\n* Pregnant or lactating women expected to undergo a cesarean section during labor and delivery;\n* The investigator concludes that the patient possesses other conditions rendering them ineligible for trial participation.",true,"ALL","18 Years",{"count":19,"type":20},564,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. This study aims to investigate the following aspects: the incidence of adverse respiratory and circulatory events requiring medical intervention following the administration of dexmedetomidine nasal spray for pre-anesthetic sedation, its sedative efficacy and onset time, and its impact on the quality of post-anesthesia recovery and the occurrence of postoperative delirium. Researchers will compare dexmedetomidine hydrochloride nasal spray to a placebo (a look-alike substance that contains no drug) to see the incidence and severity of adverse events following administration. Participants will receive either dexmedetomidine nasal spray or a placebo 45 minutes before anesthesia induction. The blinded assessor will continuously monitor and record vital signs, adverse events, and the level of sedation. More importantly, observations and records should be made for respiratory and circulatory events that require medical intervention. A follow-up assessment will be conducted within three days after the operation to evaluate the incidence of postoperative delirium and patient satisfaction.",[26,27,28,29,30],"Dexmedetomidine","Sedation","Safety","Preanesthetic Medication","Monitored Anaesthesia Care",[26,27,28,29,30,32],"Adverse Events of Respiratory Circulation","NOT_YET_RECRUITING","2025-12-22",{"date":36,"type":37},"2025-12-23","ACTUAL",{"date":39,"type":20},"2026-01-10",{"date":41,"type":20},"2026-12-30",{"name":43,"class":44},"Sichuan Provincial People's Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100615491","the-pneumorator-study-100615491","NCT07293299","The PneumoRator Study","Clinical Validation of the PneumoRator Respiratory Rate Sensor in a Perioperative Cohort","Inclusion Criteria:\n\n1. Have undergone or are referred for CPET\n2. are scheduled for elective surgery and expected to have \\>24 hours postoperative hospital stay\n3. Will be admitted to the Surgical High Dependancy Unit (SHDU) as part of their planned care\n4. will receive invasive arterial pressure monitoring as part of routine care\n5. are aged 18 or over\n6. have the capacity to give consent to participate\n\nExclusion Criteria:\n\n1. do not proceed to surgery following CPET referral\n2. are aged less than 18 years\n3. do not have capacity to consent\n4. decline to consent\n5. have sensitivity or allergy to medical adhesives\n6. patients with fragile, erythematous, or broken skin at the site of PnemoRator attachment or any other condition which, in the view of the clinical research team, may mean that the use of the PnemoRator device and adhesive is likely to cause patient harm.\n7. patients with implantable electronic medical devices (e.g. pacemakers, nerve stimulators)",{"count":53,"type":20},50,"OBSERVATIONAL","Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn't a machine that does this well enough for breathing rate to be used in most places. The machines that do exist are either uncomfortable or don't work well on patients who are moving. Instead, a healthcare worker will count the number of breaths a patient takes. This needs staff time and isn't very accurate.\n\nIt is known that changes in breathing rate can happen any time. But healthcare systems normally only measure it every few hours because it takes time. Breathing rate could be monitored all the time, we might pick up people getting sick earlier and be able to treat them more quickly, which could save lives.\n\nA team at the University of Southampton has made a small device, called a PneumoRator, that gets stuck to onto a person's chest. Once stuck there it can measure their breathing rate and store or send that information wirelessly. The device has been tested on healthy volunteers but has never been tested on patients in hospital.\n\nIn this study the team will put the device on patients having major operations. The investigators will record information already collected about patients during normal care. This includes their breathing rate using the best measurement we have, where a patient's breathing is measured by a gas they breathe out. The gas is carbon dioxide, and the measurement is called capnography. This way of measuring is only used in operating theatres and intensive care units but is a good way to check if the PneumoRator is accurate.\n\nThe investigators want to attach the PneumoRator to patient's chests before they go to sleep for their operation and leave it there for the first few days after their operation. This will let them see how the PneumoRator compares to capnography and manual breath counting. It will also let them see how the device works at different times in the patient's journey. The investigators will look at the time when patients are asleep, when breathing is controlled by a machine. Then when patients wake up investigators can measure with both capnography and the PneumoRator. Finally, when patients go to the high dependency ward, investigators will compare it against manual counting. The study team will also ask patients how they found wearing the device and any problems they found.\n\nWith this information the investigators hope to show the PenumoRator is accurate at measuring breathing rate and comfortable for patients. This will help them get the device approved for use in hospitals and other places where breathing rate needs to be measured accurately.",[57,30,58],"Respiratory","Perioperative",[60,61,62,63],"monitoring","respiratory rate","sensor","wearable","RECRUITING","2025-12-16",{"date":67,"type":37},"2025-12-19",{"date":69,"type":37},"2025-04-25",{"date":71,"type":20},"2026-04-24",{"name":73,"class":44},"University Hospital Southampton NHS Foundation Trust",1]