Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.
Drug OverdoseOverdose of Beta-adrenergic Blocking Drug1 moreThe aim of this study is to investigate whether intravenous lipid emulsion is effective in attenuating the clinical effects of a cardioactive drug, exemplified by the beta-blocking agent metoprolol. In addition, the investigators will clarify how intravenous lipid emulsion affects the pharmacokinetic parameters of metoprolol.
Naloxone Auto-injection in Healthy Volunteers
Overdose AntidoteThis study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.
Risks and Benefits of Naloxone Prescribing
Opioid OverdoseThis investigation is one of the first large-scale, prospective attempts to obtain data on the effectiveness of naloxone distribution among opioid-abusing populations at high risk of unintentional opioid poisoning. Specifically, opioid abusers will be recruited from drug detoxification sites as well as those accessing services at needle exchange programs. All participants (N=700) will receive the standard opioid overdose education and naloxone. One third of the participants will be randomized to receive additional in-depth psychosocial education focusing on recognition and prevention of opioid overdose, and appropriate use of naloxone. Another third of the participants will receive the extensive training and be required to engage a spouse, partner, relative, or friend in this supplementary intervention. The investigators plan to randomize individuals to each group [Treatment as Usual (TAU) vs. Extensively Trained (ET) vs. Extensively Trained with a Significant Other (ETwSO)] and, through continued follow up over one year, the investigators will compare self-reported overdose reversal attempts (with and without naloxone use), naloxone-related adverse events, and changes in patterns of heroin and other drug use.
A Pilot Study of the Bioavailability of Nasal Naloxone
Drug OverdoseThe overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters: Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers Preliminary estimation of the maximum serum concentration (Cmax) of this formulation Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation Safety of the formulation
Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses
Sedative OverdoseBackground: The mechanisms of action of intravenous anesthetics are unclear and the current monitors have limitations. This signifies difficulties when assessing the correct dosage due to the considerable inter-individual variability of the patients, particularly in the elderly or seriously ill. It is necessary to customize the administration of anesthetics as underdosage can lead to the patient awareness during aggressive procedures, and over-dosage can cause serious complications and even augment mortality. Objective: To design a new monitoring system of the levels of consciousness and analgesia in anesthetized subjects which is more accurate than those currently employed. It will be based on the synchronic changes of functional magnetic resonance (fMR) and electroencephalograph (EEG) readings, and clinical responses. Methodology: Thirty healthy volunteers will be given propofol and remifentanil in different combinations, and painful stimuli will be also applied. The principal variable will be fMR images obtained by echo-planar imaging sequences. Real time will be correlated with cortical connectivity maps, EEG parameters (qCON, qNOX), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (TCI).
Pharmacodynamics and Arteriovenous Differences of Naloxone in Healthy Participants Exposed to an...
Drug OverdoseOverdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. The purpose of this study is to explore the pharmacokinetics and pharmacodynamics of naloxone in healthy volunteers under opioid influence.
Picoprep Split-dose Before Colonoscopy in Children
Sodium Picosulfate OverdoseMagnesium Sulfate Overdose3 moreBefore having a colonoscopy, it is necessary to clean the intestine well in order to have a complete view of the intestinal mucosa. Preparations consisting of osmotic agents are used to clean the intestines, which are sometimes difficult to drink. In this study we want to evaluate whether the preparation, based on sodium picosulfate plus magnesium citrate (PMC), is easier for the patient to take all day before the exam or half the day before and half the same morning of procedure and which method of intake allows the doctor to better conduct the examination. The primary objective of this study will be to compare the efficacy, tolerability and acceptability of two dosage regimens of sodium picosulfate plus magnesium citrate (PMC). Effectiveness means which of the two methods of taking the preparation works best for cleaning the intestine, with tolerability if one of the two methods is easier for the patient and with acceptability if one of the two methods is easier than the other.
Nasal Naloxone for Narcotic Overdose
Drug OverdoseThe goal of this study is to determine if nasal naloxone is inferior to standard care for naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and Scioto counties in southern Ohio will be randomized to provide either standard care or nasal (IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO) methods.
PK/PD Levobupivacaine With and Without Epinephrine After Ultrasound Guided ESP Block
Anesthetics ComplicationsAnesthetic Toxicity3 moreCurrently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery. The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block. Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.
Naloxone Nasal Spray Pharmacokinetic Study
Opioid OverdoseThis study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).