Journal of neurosurgical anesthesiology
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J Neurosurg Anesthesiol · Jan 2019
Anesthesia Exposure in Children: Practitioners Respond to the 2016 FDA Drug Safety Communication.
In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.
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J Neurosurg Anesthesiol · Jan 2019
SmartTots Outcomes Workshop 2017: Notes From a Round Table Discussion About Outcome Measures.
An important element of designing research studies is the selection of appropriate outcome measures to ensure that the question posed is properly answered given the evidence. The selection of outcome measures is especially important when tackling complex, interdisciplinary problems, where appropriate outcome measures may not be as simple as a blood test or a laboratory value. ⋯ However, as research has progressed, questions have arisen regarding the best outcome measures to use in order to detect a true effect, as well as the optimal window in which to measure. These issues were discussed in a round table meeting during the SmartTots meeting in September 2017, and a summary of the discussion is presented here.
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J Neurosurg Anesthesiol · Jan 2019
The Impact of Intraoperative Magnetic Resonance Imaging on Patient Safety Management During Awake Craniotomy.
Awake craniotomy paired with intraoperative magnetic resonance imaging (iMRI) is now the established technique for maximizing surgical resection, while preserving neurological function. However, leaving an unsecured airway patient in the iMRI gantry represents considerable risk. Our study aimed at identifying the incidence of critical adverse events in unsecured airway patients during iMRI as part of awake craniotomy. ⋯ In terms of anesthesia, concurrent use of iMRI for awake craniotomy is clinically acceptable providing potential intraoperative complications can be controlled. Further, the configuration of the iMRI scanner as well as the reduced exposure from the lower magnetic field strength was found to impact patient safety management. Therefore when a conscious patient is left in the gantry without airway support, it is advisable that levels of oxygenation and ventilation should be monitored at all times.
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The Pediatric Anesthesia and Neurodevelopment Assessment (PANDA) study team held its biennial symposium in April 2018 to discuss issues on anesthetic neurotoxicity in the developing brain. One of the sessions invited speakers with different areas of expertise to discuss "Outcomes Research in Vulnerable Pediatric Populations." The vulnerable populations included neonates, children with congenital heart disease, children from low socioeconomic status, and children with incarcerated parents. Each speaker presented some of the ongoing research efforts in these groups as well as the challenges encountered in studying them.