View clinical trials related to Sedation.
Filter by:Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.
Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients remain arousable. This makes it an ideal drug for procedures which require the patient to perform tasks, or for light sedation during procedures or in the Intensive Care Unit. Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There are several models available for dexmedetomidine at this time, but the most often used models (Dyck and Talke) underpredict the plasma concentration at higher concentrations. Also, plasma concentrations aren't what the clinician is interested in, but in the effect. Therefore, pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the drug to effect instead of plasma concentration, using TCI. This has been done for many anaesthetic drugs, but not for dexmedetomidine. Additionally, we want to investigate the effect of stimulation on the pharmacodynamic effect of dexmedetomidine. The reason for this is that patients under dexmedetomidine sedation are arousable by noises or touch. An operating room or ICU is never quiet, and there are always sounds of monitors, alarms, and talking between team members or activity around another patient in the same room, therefore the stimulation of the patient in such an environment may have a profound effect on the sedative effect of dexmedetomidine.
Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.
Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail. The purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.
EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.
The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.
Children < 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are 1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h 2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow. Hypothesis: 1. reduces recovery time compared to propofol mono sedation 2. combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation 3. combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure without intubation under monitored sedation care.
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).