Preliminary Experience With Remimazolam for Procedural Sedation and as an Adjunct to General Anesthesia During Diagnostic and Interventional Cardiac Procedures.

Background: Remimazolam is a benzodiazepine which, like midazolam, has sedative, anxiolytic, and amnestic properties. Ester metabolism results in a half-life of 5 - 10 min, a limited context sensitive half-life, and rapid recovery when the infusion is discontinued. Methods: Following the Institutional Review Board (IRB) approval, we performed a retrospective chart review of patients who received remimazolam in the cardiac catheterization, cardiac magnetic resonance imaging (MRI), and electrophysiology suites. The primary objective was to assess efficacy and safety. The secondary objective was to describe bolus and infusion dosing of remimazolam and the need for adjunctive agents to optimize procedural sedation conditions. Results: The study cohort included 26 patients with a median age of 18 years and a total of 33 anesthetic encounters. The most common procedures were endomyocardial biopsy or isolated hemodynamic assessment (right or left heart catheterization). Remimazolam was the primary agent for sedation in 82% of the procedures. The majority of cases (25 encounters, 76%) included a bolus dose of remimazolam prior to the start of an infusion. For those patients who received a starting bolus dose, dosing typically ranged between 30 and 110 µg/kg. Continuous infusion rates of remimazolam varied from 5 to 20 µg/kg/min. No adverse hemodynamic or respiratory effects were noted. Midazolam, fentanyl, and dexmedetomidine were the most frequently used adjunctive agents. One patient required transition to general anesthesia due to the need for a surgical intervention based on the findings of the cardiac catheterization. All other patients were effectively sedated. Conclusions: Our preliminary experience demonstrates that remimazolam effectively provided sedation for diagnostic and therapeutic cardiovascular procedures. Future studies are needed to further define dosing parameters for both bolus dosing and continuous infusion as well as to compare remimazolam to other commonly used for procedural sedation in patients with congenital and acquired heart disease.

Remimazolam as a Primary Agent for Brief Invasive and Noninvasive Procedures: A Case Series.

Remimazolam is a novel benzodiazepine with sedative and amnestic properties similar to midazolam. Ester metabolism results in a half-life of 5 - 10 min and a limited context sensitive half-life. We present preliminary retrospective experience with its use as a primary agent for procedural sedation for brief invasive and noninvasive procedures. The study cohort included seven patients, ranging in age from 14 to 51 years. Remimazolam administration included bolus dosing in two patients and a combination of bolus dosing followed by an infusion in the other five patients. The initial bolus dose of remimazolam ranged from 2.5 to 5 mg. Starting doses for the infusion ranged from 10 to 30 µg/kg/min with titration of the continuous infusion during the procedure, ranging from 10 - 30 µg/kg/min. Median dose infusion requirements were 15 - 20 µg/kg/min. One procedure was completed with remimazolam as the sole anesthetic agent while the other six patients received adjunctive agents. Changes in blood pressure or oxygen saturation were noted which resolved with minimal interventions such as a decrease in remimazolam infusion rate or an increase in supplemental oxygen administration. Our anecdotal experience provides further support for the efficacy of remimazolam as an agent for procedural sedation.

Prothrombin Complex Concentrates to Treat Coagulation Disturbances: An Overview With a Focus on Use in Infants and Children.

Various factors may lead to coagulation disturbances following cardiopulmonary bypass and surgery for congenital heart disease. In addition to the risks associated with the administration of allogeneic blood products, persistent disturbances in coagulation function and ongoing bleeding may lead to prolonged surgical times, hemodynamic alterations, intracranial hemorrhage, and even mortality. In most clinical scenarios, coagulation disturbances are treated by targeted blood product therapy including fresh frozen plasma, platelet transfusions, or the administration of cryoprecipitate. When routine blood product therapy fails, coagulation adjuncts such as activated recombinant factor VII or prothrombin complex concentrates (PCCs) may be an option to rapidly replenish depleted coagulation factors and correct coagulation disturbances. The PCC formulations including three-factor PCC, four-factor PCC, and factor eight-inhibitor bypass activator (FEIBA) have been used mainly in the adult population with sporadic case series and anecdotal reports in the pediatric population. The following manuscript discusses the various PCC products available for clinical use, reviews previous reports of their use in infants and children with an emphasis on their role following surgery for congenital heart disease, and outlines their potential role in these clinical scenarios.

The Incidence and Severity of Hypocarbia in Neonates Undergoing General Anesthesia.

BACKGROUND: Extended periods of hypocarbia in preterm infants may be associated with intraventricular hemorrhage, periventricular leukomalacia, and bronchopulmonary dysplasia. To evaluate the current anesthetic practice in preterm neonates, we retrospectively reviewed the intraoperative course with regard to [Formula: see text] and ventilation during non-cardiac surgical procedures in infants <60 weeks postmenstrual age. METHODS: This was a single-center, retrospective study during non-cardiac surgical procedures in neonates. Hyperventilation was defined as a [Formula: see text] ≤ 35  mm  Hg, significant hyperventilation as a [Formula: see text] ≤ 30 mm Hg, and extreme hyperventilation as a [Formula: see text] ≤ 25  mm  Hg. RESULTS: The study cohort included 112 neonates, with a median postnatal age of 40 weeks, median gestational age of 38 weeks, and median weight of 5 kg. Thirty-seven subjects (33%) had at least one arterial blood gas value that demonstrated hyperventilation. Thirteen (12%) were noted to have significant hyperventilation ([Formula: see text] ≤ 30  mm  Hg) and 2 had extreme hyperventilation ([Formula: see text] ≤ 25  mm  Hg). CONCLUSIONS: The incidence of at least one arterial blood gas that demonstrated inadvertent hyperventilation in neonates was high during intraoperative care. These data may provide the baseline for future studies that address more rigorous monitoring and control of [Formula: see text] during intraoperative care. Although the duration of the anesthetic care and surgical procedure is brief compared with the neonatal ICU length of stay because there is no demonstrated benefit of hypocapnia and, in fact, well-documented harm associated with hyperventilation in neonates, care should be directed at limiting inadvertent hyperventilation. (ClinicalTrials.gov registration NCT03823716.).

Inadvertent hyperoxia during intraoperative care in neonates: a case-series study.

While oxygen administration has been in clinical practice, the focus has generally been on avoidance of hypoxemia. More recently, renewed emphasis has been placed on the potential deleterious effects of hyperoxia. The aim of this study is to investigate the incidence of intraoperative inadvertent hyperoxia among neonate, which was defined at three different thresholds: normoxia (PaO2 60-100 mmHg), hyperoxia (PaO2 101-199 mmHg), and severe hyperoxia (PaO2 ≥ 200 mmHg). This study included 65 patients with 174 eligible arterial blood gas (ABG) samples, who were less than 60 weeks post-menstrual age and required a non-cardiac surgical procedure. Among the 65 patients, 62 (96%) patients experienced either hyperoxia or severe hyperoxia during general anesthesia on at least one ABG. Among the 174 ABG readings, only 28 (16%) had PaO2 levels within our defined normoxia range. The incidence of hyperoxia in neonate under general anesthesia is high. Although it is unknown if brief exposure during anesthesia is associated with similar outcomes, educational initiatives seem warranted to increase awareness of these clinical concerns, as there seems to be limited clinical benefit from such care.

Regional Anesthesia Facilitates the Early Recognition of Local Anesthetic Toxicity.

Rising concerns regarding the potential long-term neurocognitive effects of general anesthetic agents have renewed an interest in using regional anesthesia instead of general anesthesia in infants. Although generally safe and effective, the primary risk associated with regional anesthesia relates to the use of large doses of local anesthetic agents and the potential for local anesthetic systemic toxicity (LAST). We present three infants who suffered LAST after receiving regional anesthesia instead of general anesthesia. The early signs and symptoms were quickly identified in the awake state thereby allowing for cessation of continuous drug administration and a rapid response to treat LAST before progression to severe sequelae.

Sustainability of protocolized handover of pediatric cardiac surgery patients to the intensive care unit.

BACKGROUND: Transfer of patient care among clinicians (handovers) is a common source of medical errors. While the immediate efficacy of these initiatives is well documented, sustainability of practice changes that results in better processes of care is largely understudied. AIMS: The objective of the current investigation was to evaluate the sustainability of a protocolized handover process in pediatric patients from the operating room after cardiac surgery to the intensive care unit. METHODS: This was a prospective study with direct observation assessment of handover performance conducted in the cardiac ICU (CICU) of a free-standing, tertiary care children's hospital in the United States. Patient transitions from the operating room to the CICU, including the verbal handoff, were directly observed by a single independent observer in all phases of the study. A checklist of key elements identified errors classified as: (1) technical, (2) information omissions, and (3) realized errors. Total number of errors was compared across the different times of the study (preintervention, postintervention, and the current sustainability phase). RESULTS: A total of 119 handovers were studied: 41 preintervention, 38 postintervention, and 40 in the current sustainability phase. The median [Interquartile range (IQR)] number of technical errors was significantly reduced in the sustainability phase compared to the preintervention and postintervention phase, 2 (1-3), 6 (5-7), and 2.5 (2-4), respectively P = 0.0001. Similarly, the median (IQR) number of verbal information omissions was also significantly reduced in the sustainability phase compared to the preintervention and postintervention phases, 1 (1-1), 4 (3-5) and 2 (1-3), respectively. CONCLUSIONS: We demonstrate sustainability of an improved handover process using a checklist in children being transferred to the intensive care unit after cardiac surgery. Standardized handover processes can be a sustainable strategy to improve patient safety after pediatric cardiac surgery.