View clinical trials related to Procedural Sedation.
Filter by:Endoscopic procedures are commonly performed using sedation. As drug-induced respiratory depression is a major cause of sedation-related morbidity, pulse oximetry has been established as standart practice . However SpO2 does not completely reflect ventilation. Capnography is an additional monitoring parameter which demonstrates respiration activity breath by breath. Unfortunately, in the state of moderate or deep sedation during diagnostic or therapeutic procedures (e.g.ERCP or colonoscopies), regular breathing is often disturbed by moving, squeezing, coughing or changes between nose and mouth ventilation causing leakage and therefore artifacts or misinterpretation of data acquired with ETCO2. These problems often restrict the use of side-stream capnography in clinical practice, although the American Society of Anesthesiologists have suggested in their guidelines that extended monitoring with capnography 'should be considered'in deep sedation. The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg). The ORI is an "index" with a unit-less scale between 0.00 and 1.00 that can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen status. When utilized in conjunction with SpO2 monitoring the ORI may extend the visibility of a patient's oxygen status into ranges previously unmonitored in this fashion. The ORI may make pre-oxygenation visible, may provide early warning when oxygenation deteriorates, and may facilitate a more precise setting of the required FiO2 level. In this study we aimed to show effectivity of capnography and ORİ monitoring to avoid respiratory events and hypoxia in sedated endoscopic patients. In this study we targeted totally 300 sedated endoscopy patients. Patients will randomize to two groups. In Group I anaesthesiologis will be able to use all the monitoring, where as in Group II will be blinded for ORİ. We will apply pre-oxygenation to obtain long safe apnea time. Approximately 5 min pre-oxygenation (5L/min via nasal cannula) will be used to reach steady state in oxygen reserve. We defined hypoxemia ; SpO2<95% and severe hypoxemia SpO2≤90%, hypoventilation; rise10 mmHg in ETCO2 compare to baseline, ETCO2≤30 mmHg and flat capnography.
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
Children's compliance during diagnostic or therapeutic procedures is a challenge, often requiring the use of sedative and/or analgesic drugs. Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time, the use of any drug for sedation may affect the exam through an interference with EEG waves. Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties, with a long effect and which does not alter EEG pattern. The aim of this interventional study is to evaluate the effectiveness, safety and feasibility of dexmedetomidine for sedation during EEG in children who are not cooperative. Children affected by behavioral disorders and requiring sedation to perform EEG were considered. The protocol establishes to administer IV dexmedetomidine (loading dose and continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale = 2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during and after procedure until the offset.
Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age. If untreated it carries a poor prognosis, leading to heart failure and death in 2 years after first symptom presentation. Treatment of choice for severe aortic stenosis is surgical aortic valve replacement. A new treatment option for severe aortic stenosis emerged in the last decade - Transcatheter Aortic Valve Replacement (TAVR). This minimally invasive method was formerly reserved for high risk patients deemed unfit for surgical aortic valve replacement. Increasing use throughout the developed world and recent studies have established TAVR as a safe and viable treatment option also for intermediate-risk patients. TAVR not only enables a less aggressive surgical approach, but also a less invasive type of anaesthesia. Anaesthesiologists are trying to modify the type of anaesthesia in the way of minimally invasive approach, aiming to improve the overall outcome. TAVR can be performed under general anaesthesia or procedural sedation (PS). From the start, TAVR was performed solely under general anaesthesia. Over time the procedure became routine and the anaesthesiologists started to commonly decide for PS. Many US and European retrospective studies have established PS to be a safe and compelling method of anaesthetic care for TAVR procedures with a favorable perioperative course, less complications, shorter intensive care unit and in-hospital stay and lower early mortality, when performed by an experienced anaesthesia team. There are many anaesthesia agents currently accepted for PS in everyday anaesthesia practice. Presently, reliable data from studies comparing different agents for PS for TAVR procedures is scarce. Most of it comes from retrospective nonrandomized trials. Propofol is a popular anaesthetic agent for PS. According to current studies, it is a safe anaesthetic agent with favorable pharmacokinetic and pharmacodynamic profiles with quite low incidence of side effects. In recent years, dexmedetomidine has been commonly used for PS having analgesic properties inclusive of its anaesthetic properties. In addition, dexmedetomidine is associated with a lesser degree of respiratory depression as to other anaesthetic agents. Patient comfort is also believed to be improved with dexmedetomidine. Studies comparing outcomes of PS with propofol versus dexmedetomidine for different non-cardiac and interventional procedures showed benefits of dexmedetomidine, owing to its analgesic properties and preferable respiratory parameters. The aim of this study is to compare the outcome of patients undergoing TAVR under PS with dexmedetomidine against those undergoing TAVR under PS with propofol. With the results the investigators aim to aid in defining the optimal anaesthetic agent for PS for TAVR and possibly other interventional cardiology procedures.
A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in healthy subjects and compared to an intravenous control
We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.
The main objective is to determine if dexmedetomidine combine with alfentanil allow a level of conscious sedation within maximum security conditions in an emergency department. Patients included in the study will receive an injection of dexmedetomidine via a TIVA Injectomat Agilia, specially programmed for the injection of dexmedetomidine. Patients will also receive a dose of alfentanil, 1 minute before the technical act.
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.
To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.
This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.