Determination of the optimal dose of ephedrine in the treatment of arterial hypotension due to general anesthesia in neonates and infants below 6 months old: the ephedrine study protocol for a randomized, open-label, controlled, dose escalation trial.

BACKGROUND: Arterial hypotension induced by general anesthesia is commonly identified as a risk factor of morbidity, especially neurological, after cardiac or noncardiac surgery in adults and children. Intraoperative hypotension is observed with sevoflurane anesthesia in children, in particular in neonates, infants younger than 6 months, and preterm babies. Ephedrine is commonly used to treat intraoperative hypotension. It is an attractive therapeutic, due to its dual action on receptors alpha and beta and its possible peripheral intravenous infusion. There are few data in the literature on the use of ephedrine in the context of pediatric anesthesia. The actual recommended dose of ephedrine (0.1 to 0.2 mg/Kg) frequently leads to a therapeutic failure in neonates and infants up to 6 months of age. The use of higher doses would probably lead to a better correction of hypotension in this population. The objective of our project is to determine the optimal dose of ephedrine for the treatment of hypotension after induction of general anesthesia with sevoflurane, in neonates and infants up to 6 months of age. METHODS: The ephedrine study is a prospective, randomized, open-label, controlled, dose-escalation trial. The dose escalation consists of 6 successive cohorts of 20 subjects. The doses studied are 0.6, 0.8, 1, 1.2, and 1.4 mg/kg. The dose chosen as the reference is 0.1 mg/kg, the actual recommended dose. Neonates and infants younger than 6 months, males and females, including preterm babies who undergo a surgery with general anesthesia inducted with sevoflurane were eligible. Parents of the subject were informed. Then, the subjects were randomized if presenting a decrease in mean blood pressure superior to 20% of their initial mean blood pressure (before induction of anesthesia), despite a vascular filling with sodium chloride 0.9%. The primary outcome is the success of the therapy defined as an mBP superior to 80% of the baseline mBP (prior to anesthesia) within 10 min post ephedrine administration. The subjects were followed-up for 3 days postanesthesia. DISCUSSION: This study is the first randomized, controlled trial intending to determine the optimal dose of ephedrine to treat hypotension in neonates and infants below 6 months old. TRIAL REGISTRATION: ClinicalTrials.gov NCT02384876 . Registered on March 2015.

The effect of pre-operative gastric ultrasound examination on the choice of general anaesthetic induction technique for non-elective paediatric surgery. A prospective cohort study.

Ultrasound examination of the gastric antrum is a non-invasive tool that allows reliable estimation of gastric contents. We performed this prospective cohort study in non-elective paediatric surgery to assess whether gastric ultrasound may help to determine the best anaesthetic induction technique, whether rapid sequence or routine. The primary outcome was the reduction of inappropriate induction technique. A pre-operative clinical assessment was performed by the attending anaesthetist who made a provisional plan for induction. Gastric ultrasound was performed in the semirecumbent and right lateral decubitus positions for a qualitative assessment of gastric contents, using a 0-2 grading scale. A final induction plan was made based on this assessment. Immediately after tracheal intubation, gastric contents were suctioned through a multi-orifice nasogastric tube; these were defined as above risk threshold for regurgitation and aspiration if there was clear fluid > 0.8 ml.kg-1 , and/or the presence of thick fluid and/or solid particles. Gastric ultrasound was feasible in 130 out of 143 (90%) of children, and led to a change in the planned induction technique in 67 patients: 30 from routine to rapid sequence, and 37 from rapid sequence to routine. An appropriate induction technique was therefore performed in 85% of children, vs. 49% planned after pre-operative clinical assessment alone (p < 0.00001). Our results suggest that gastric ultrasound is a useful guide to the general anaesthetic induction technique with respect to the risk of pulmonary aspiration, in comparison with pre-operative clinical assessment alone.

Ultrasound assessment of gastric contents in children undergoing elective ear, nose and throat surgery: a prospective cohort study.

Ultrasound examination of the gastric antrum allows reliable assessment of gastric contents and volume. Postoperative assessment of gastric contents before recovery from anaesthesia could help the physician to choose the most appropriate extubation technique after surgery in children. In this prospective observational study, we assessed whether significant changes occurred in gastric contents during the intra-operative period in children undergoing elective ear, nose and throat (ENT) surgery. Children aged between six months and 16 years were recruited consecutively. Ultrasound examination of the antrum was performed before induction of anaesthesia and at the end of surgery before tracheal extubation, and included quantitative and qualitative assessment of gastric contents. The mean (SD) gastric volume was 0.28 (0.30) ml.kg-1 before surgery and 0.27 (0.30) ml.kg-1 after surgery, p = 0.82. No solid contents were identified in the antrum, and the gastric volume was < 1.5 ml.kg-1 in all patients during both ultrasound examinations. Our results suggest that, after elective ENT surgery, children are not at risk of a full stomach before tracheal extubation, and that pulmonary aspiration of blood that may occur after elective ENT surgery is probably not related to regurgitation of ingested blood from the stomach.

Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction.

BACKGROUND: The operating theatre, anaesthesia induction and separation from parents create fear and anxiety in children. Anxiety leads to adverse behavioral changes appearing and sometimes persisting during the postoperative period. Our aim was to compare the effects of midazolam (0.3 mg kg-1: MDZ) for premedication with age-appropriate tablet game apps (TAB) on children anxiety during and after ambulatory surgery. METHODS: A randomized controlled trial was conducted from May 16th, 2013 to March 25th, 2014 at the Children Hospital of Lyon. The primary outcome of this study was the change in m-YPAS score at the time of anaesthetic mask induction. Anxiety was also assessed in the waiting surgical area, at the time of separation with parents and when back in the ambulatory surgery ward. RESULTS: One hundred and eighteen patients aged four-11 yr were recruited, 60 in the TAB Group and 58 in the MDZ Group. Main endpoint was missing for three patients from the MDZ Group. At the time of mask induction, there was no significant difference between MDZ and TAB Group for the m-YPAS score (40.5 (18.6) vs 41.8 (20.7), P = 0.99). There was no significant correlation between m-YPAS score and its evolution over the four period of time between subjects. CONCLUSIONS: We were not able to show whether TAB is superior to MDZ to blunt anxiety in children undergoing ambulatory surgery. TAB is a non-pharmacological tool which has the capacity in reducing perioperative stress without any sedative effect in this population. CLINICAL TRIAL REGISTRATION: NCT 02192710.

Ultrasound assessment of the gastric contents for the guidance of the anaesthetic strategy in infants with hypertrophic pyloric stenosis: a prospective cohort study.

BACKGROUND: Evacuation of gastric content through a nasogastric tube, followed by rapid sequence induction, is usually recommended in infants undergoing pyloromyotomy. However, rapid sequence induction may be challenging, and is therefore controversial. Some anaesthetists regularly perform classical non-rapid induction technique, after blind aspiration of the gastric contents, although this aspiration may have been incomplete. This prospective observational study aimed to assess whether the ultrasound monitoring of the aspiration of the stomach contents, may be useful to appropriately guide the choice of the anaesthetic induction technique, in infants undergoing pyloromyotomy. METHODS: Infants undergoing pyloromyotomy were consecutively included. Ultrasound assessment of the antrum was performed before and after the aspiration of the gastric contents through a 10 French gastric tube. The stomach was defined as empty when no content was seen in both supine and right lateral positions. The correlation between antral area and the aspirated gastric volume was also tested. RESULTS: We analysed 34 infants. Ultrasound examination of the antrum failed in three infants. The stomach was empty in 30/34 infants (nine before aspiration, 21 after aspiration), allowing to perform a non-rapid induction technique in 88.2% of the infants. There was a significant correlation between antral area measured in right lateral decubitus and the aspirated gastric volume. CONCLUSIONS: Our results suggest that the qualitative ultrasound assessment of the antral content may be a simple and useful point-of-care tool, for the choice of the most appropriate anaesthetic technique for pyloromyotomy according to the estimated risk of pulmonary aspiration of gastric contents.

Resuscitation with lipid, epinephrine, or both in levobupivacaine-induced cardiac toxicity in newborn piglets.

BACKGROUND: The optimal dosing regimens of lipid emulsion, epinephrine, or both are not yet determined in neonates in cases of local anaesthetic systemic toxicity (LAST). METHODS: Newborn piglets received levobupivacaine until cardiovascular collapse occurred. Standard cardiopulmonary resuscitation was started and electrocardiogram (ECG) was monitored for ventricular tachycardia, fibrillation, or QRS prolongation. Piglets were then randomly allocated to four groups: control (saline), Intralipid(®) alone, epinephrine alone, or a combination of Intralipd plus epinephrine. Resuscitation continued for 30 min or until there was a return of spontaneous circulation (ROSC) accompanied by a mean arterial pressure at or superior to the baseline pressure and normal sinus rhythm for a period of 30 min. RESULTS: ROSC was achieved in only one of the control piglets compared with most of the treated piglets. Mortality was not significantly different between the three treatment groups, but was significantly lower in all the treatment groups compared with control. The number of ECG abnormalities was zero in the Intralipid only group, but 14 and 17, respectively, in the epinephrine and epinephrine plus lipid groups (P<0.05). CONCLUSIONS: Lipid emulsion with or without epinephrine, or epinephrine alone were equally effective in achieving a return to spontaneous circulation in this model of LAST. Epinephrine alone or in combination with lipid was associated with an increased number of ECG abnormalities compared with lipid emulsion alone.