4 research outputs found

    Peri-operative red blood cell transfusion in neonates and infants: NEonate and Children audiT of Anaesthesia pRactice IN Europe: A prospective European multicentre observational study

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    BACKGROUND: Little is known about current clinical practice concerning peri-operative red blood cell transfusion in neonates and small infants. Guidelines suggest transfusions based on haemoglobin thresholds ranging from 8.5 to 12 g dl-1, distinguishing between children from birth to day 7 (week 1), from day 8 to day 14 (week 2) or from day 15 (≥week 3) onwards. OBJECTIVE: To observe peri-operative red blood cell transfusion practice according to guidelines in relation to patient outcome. DESIGN: A multicentre observational study. SETTING: The NEonate-Children sTudy of Anaesthesia pRactice IN Europe (NECTARINE) trial recruited patients up to 60 weeks' postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries between March 2016 and January 2017. PATIENTS: The data included 5609 patients undergoing 6542 procedures. Inclusion criteria was a peri-operative red blood cell transfusion. MAIN OUTCOME MEASURES: The primary endpoint was the haemoglobin level triggering a transfusion for neonates in week 1, week 2 and week 3. Secondary endpoints were transfusion volumes, 'delta haemoglobin' (preprocedure - transfusion-triggering) and 30-day and 90-day morbidity and mortality. RESULTS: Peri-operative red blood cell transfusions were recorded during 447 procedures (6.9%). The median haemoglobin levels triggering a transfusion were 9.6 [IQR 8.7 to 10.9] g dl-1 for neonates in week 1, 9.6 [7.7 to 10.4] g dl-1 in week 2 and 8.0 [7.3 to 9.0] g dl-1 in week 3. The median transfusion volume was 17.1 [11.1 to 26.4] ml kg-1 with a median delta haemoglobin of 1.8 [0.0 to 3.6] g dl-1. Thirty-day morbidity was 47.8% with an overall mortality of 11.3%. CONCLUSIONS: Results indicate lower transfusion-triggering haemoglobin thresholds in clinical practice than suggested by current guidelines. The high morbidity and mortality of this NECTARINE sub-cohort calls for investigative action and evidence-based guidelines addressing peri-operative red blood cell transfusions strategies. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02350348

    A randomised controlled trial on postoperative analgesia in prostatectomy with continuous infusion of tramadol and ketamine and electroacupuncture application

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    The aim is to study the analgesic effect of electroacupuncture as perioperative adjunctive therapy added to a systemic analgesic strategy (including tramadol+ ketamine) for postoperative pain, opioid-related side effects and patient satisfaction. 75 patients undergoing radical prostatectomy were randomly assigned to two groups: “TKB” (n=37) Tramadol+Ketamine+Electroacupuncture and “TK” (n=38) Tramadol+Ketamine. In TKB group electroacupuncture applied at 100 Hz frequency at LI4 bilaterally during the closure of the abdominal walls and at 4 Hz at ST36 and LI4 bilaterally just after extubation. In “TK” group the needles were placed and secured by adhesive tape, without inserting the skin, at the same accu-points. The electrodes were connected to each other and the stimulator light was on but no electrical current was applied. Postoperative pain was evaluated by recording patients’ pain using Numerical Rating Scale (NRS), McGill Scale (SF_MPQ), mechanical pain thresholds after algometer application close to the wound, cortisol measurements, rescue analgesia, Spielberger State Trait Anxiety Inventory (STAI Y-6 item), patient satisfaction and side effects. A total of seventy patients completed the study with 35 patients in each group. Pain scores on the NRS and SF_MPQ were significant lower and electronic pressure algometer measurements were significant higher in the “EA” group compared to the “Control” group (p<0.001) at all assessments. Significant decrease in rescue analgesia was observed at 45 min in the “EA” group (p<0.001) and a significant decrease in cortisol levels was observed in the “EA” group (p<0.05) for CORT3. Patients were significant satisfied with analgesia, especially in the “EA” group (p<0.01). A small percentage of patients reported adverse effects and no significant differences between groups were observed except for the beginning of bowel movements. Significant delays in the beginning of bowel movements were observed in the “Control” group at 45 min (p<0.001) and 2 h (p<0.05). In conclusion, the application of EAc as adjunctive therapy in combination with tramadol plus ketamine perioperatively decreased postoperative pain in patients undergoing radical prostatectomy and the adverse effects of opioids and these patients were more positive and improved feelings of wellbeing.Σκοπός ήταν η μελέτη της αποτελεσματικότητας της εφαρμογής της τεχνικής του ηλεκτροβελονισμού (Η/Β) σα συμπληρωματική θεραπεία περιεγχειρητικά στα πλαίσια ενός μοντέλου πολυπαραγοντικής αναλγησίας σε συνδυασμό με ευρύτερα χρησιμοποιούμενα αναλγητικά από την ενδοφλέβια οδό όπως τραμαδόλη και κεταμίνη στους ασθενείς που υποβλήθηκαν σε ριζική προστατεκτομή, η συχνότητα εμφάνισης ανεπιθύμητων ενεργειών και η ικανοποίηση και ευφορία των ασθενών από την εφαρμοσθείσα τεχνική. 75 ασθενείς που υποβλήθηκαν σε ριζική προστατεκτομή χωρίστηκαν με τυχαιοποίηση σε 2 ομάδες την ΤΚΒ (n= 37): τραμαδόλη + κεταμίνη + Η/Β και την ΤΚ (n= 38): τραμαδόλη + κεταμίνη. Στους ασθενείς της ομάδας ΤΚΒ όταν άρχιζε η συρραφή των κοιλιακών τοιχωμάτων τοποθετούνταν βελόνες στα σημεία LI 4 και στα δύο άνω άκρα και εφαρμοζόταν Η/Β για 30 min σε συχνότητα 100 Hz και αμέσως μετά την αποδιασωλήνωση τους στα σημεία ST 36 και LI 4 για 30 min σε συχνότητα 4 Hz. Στην ομάδα ΤΚ οι βελόνες τοποθετούνταν πάνω σε αυτοκόλλητες ταινίες στα ίδια σημεία χωρίς να διαπερνούν το δέρμα των ασθενών. Τα ηλεκτρόδια συνδέονταν κατά ζεύγη και το Η/Β μηχάνημα ενώ ήταν ανοικτό δεν ήταν προγραμματισμένο να χορηγεί ηλεκτρικό ρεύμα. Η εκτίμηση των ασθενών γινόταν με καταγραφή της έντασης του πόνου σε κίνηση και ακινησία με τις κλίμακες εκτίμησης του πόνου ΝRS, PPI, SF-_MPQ και την εφαρμογής της συσκευής του αλγόμετρου εκατέρωθεν του μέσου της χειρουργικής τομής και καταγραφής του ουδού του πόνου, της κορτιζόλης του ορού, της συμπληρωματικής αναλγησίας, της εκτίμησης του άγχους με την κλίμακα STAI, της ικανοποίησης τους και των ανεπιθύμητων ενεργειών. Μελετήθηκαν συνολικά 70 ασθενείς, 35 σε κάθε ομάδα. Η εκτίμηση της έντασης του πόνου των ασθενών με την κλίμακα NRS, την κλίμακα PPI και την τροποποιημένη κλίμακα McGill (SF_MPQ) έδειξε στατιστικά σημαντική μείωση της έντασης του πόνου στην ανάπαυση και στην κίνηση και στατιστικά σημαντική αύξηση του ουδού του πόνου με τη χρήση του αλγόμετρου σε όλες τις εκτιμήσεις στην ομάδα ΤΚΒ σε σχέση με την ΤΚ (p<0.001). Υπήρξε στατιστικά σημαντική μείωση στη χορήγηση συμπληρωματικής αναλγησίας ιδίως στα 45 min μετά την επέμβαση (p<0.001) στην ομάδα ΤΚΒ και στατιστικά σημαντική μείωση των τιμών της κορτιζόλης στο αίμα στη χρονική στιγμή CORT3 (p<0.05) στην ομάδα ΤΚΒ. Οι ασθενείς ήταν ευχαριστημένοι από την αναλγητική τεχνική που τους εφαρμόστηκε ιδίως στην ομάδα ΤΚΒ (p<0.01). Ένα πολύ μικρό ποσοστό των ασθενών εμφάνισε κάποιες ανεπιθύμητες ενέργειες από τη χρήση των οπιοειδών και όχι όλες ταυτόχρονα εκτός από την έναρξη κινητοποίησης του εντέρου. Στην ομάδα ΤΚ υπήρξε στατιστικά σημαντική καθυστέρηση στην έναρξη της κινητοποίησης του εντέρου στα 45 min (p≤0.001) και στις 2 h (p≤0.05). Η εφαρμογή της τεχνικής του ηλεκτροβελονισμού σα συμπληρωματική θεραπεία σε συνδυασμό με τραμαδόλη και κεταμίνη διεγχειρητικά και άμεσα μετεγχειρητικά μείωσε την ένταση του πόνου των ασθενών που υποβλήθηκαν σε επέμβαση ριζικής προστατεκτομής, μείωσε τη συχνότητα εμφάνισης των ανεπιθύμητων ενεργειών από τη χρήση των οπιοειδών και οι ασθενείς είναι πιο ικανοποιημένοι και με ένα αίσθημα ευφορίας

    Morbidity and mortality after anaesthesia in early life: results of the European prospective multicentre observational study, neonate and children audit of anaesthesia practice in Europe (NECTARINE)

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    Background: Neonates and infants requiring anaesthesia are at risk of physiological instability and complications, but triggers for peri-anaesthetic interventions and associations with subsequent outcome are unknown. Methods: This prospective, observational study recruited patients up to 60 weeks' postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries between March 2016 and January 2017. The primary aim was to identify thresholds of pre-determined physiological variables that triggered a medical intervention. The secondary aims were to evaluate morbidities, mortality at 30 and 90 days, or both, and associations with critical events. Results: Infants (n=5609) born at mean (standard deviation [sd]) 36.2 (4.4) weeks postmenstrual age (35.7% preterm) underwent 6542 procedures within 63 (48) days of birth. Critical event(s) requiring intervention occurred in 35.2% of cases, mainly hypotension (&gt;30% decrease in blood pressure) or reduced oxygenation (SpO2 &lt;85%). Postmenstrual age influenced the incidence and thresholds for intervention. Risk of critical events was increased by prior neonatal medical conditions, congenital anomalies, or both (relative risk [RR]=1.16; 95% confidence interval [CI], 1.04-1.28) and in those requiring preoperative intensive support (RR=1.27; 95% CI, 1.15-1.41). Additional complications occurred in 16.3% of patients by 30 days, and overall 90-day mortality was 3.2% (95% CI, 2.7-3.7%). Co-occurrence of intraoperative hypotension, hypoxaemia, and anaemia was associated with increased risk of morbidity (RR=3.56; 95% CI, 1.64-7.71) and mortality (RR=19.80; 95% CI, 5.87-66.7). Conclusions: Variability in physiological thresholds that triggered an intervention, and the impact of poor tissue oxygenation on patient's outcome, highlight the need for more standardised perioperative management guidelines for neonates and infants

    Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study

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    International audienceBackground: Neonates and infants are susceptible to hypoxaemia in the perioperative period. The aim of this study was to analyse interventions related to anaesthesia tracheal intubations in this European cohort and identify their clinical consequences.Methods: We performed a secondary analysis of tracheal intubations of the European multicentre observational trial (NEonate and Children audiT of Anaesthesia pRactice IN Europe [NECTARINE]) in neonates and small infants with difficult tracheal intubation. The primary endpoint was the incidence of difficult intubation and the related complications. The secondary endpoints were the risk factors for severe hypoxaemia attributed to difficult airway management, and 30 and 90 day outcomes.Results: Tracheal intubation was planned in 4683 procedures. Difficult tracheal intubation, defined as two failed attempts of direct laryngoscopy, occurred in 266 children (271 procedures) with an incidence (95% confidence interval [CI]) of 5.8% (95% CI, 5.1-6.5). Bradycardia occurred in 8% of the cases with difficult intubation, whereas a significant decrease in oxygen saturation (SpO2<90% for 60 s) was reported in 40%. No associated risk factors could be identified among co-morbidities, surgical, or anaesthesia management. Using propensity scoring to adjust for confounders, difficult anaesthesia tracheal intubation did not lead to an increase in 30 and 90 day morbidity or mortality.Conclusions: The results of the present study demonstrate a high incidence of difficult tracheal intubation in children less than 60 weeks post-conceptual age commonly resulting in severe hypoxaemia. Reassuringly, the morbidity and mortality at 30 and 90 days was not increased by the occurrence of a difficult intubation event
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