title: A novel isotonic balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in neonates: results of a prospective multicentre observational postauthorisation safety study (PASS).
abstract: BACKGROUND
  Neonates have a higher metabolic rate and an increased risk of perioperative hypoglycemia and lipolysis, but during anesthesia, both oxygen consumption and metabolic rate are decreased, and this may lead to reduced intraoperative glucose requirements.
  
  
  OBJECTIVE
  The objective of this prospective multicentre observational postauthorisation safety study was to evaluate the intraoperative use of a novel isotonic balanced electrolyte solution with a low glucose concentration of 1% (BS-G1) in neonates with a particular focus on changes in acid-base, electrolyte, and glucose concentrations.
  
  
  METHODS
  Following the local ethics committee approval, neonates with a postmenstrual age under 45 weeks and an ASA risk score of I-IV undergoing intraoperative administration of BS-G1 were enrolled. Patient demographics, the performed procedure, adverse drug reactions, hemodynamic data, and the results of blood gas analysis before and after infusion were documented with a focus on changes in acid-base, electrolyte, and glucose concentrations.
  
  
  RESULTS
  In 66 neonates (ASA I-IV; postmenstrual age 38 ± 4, range 25-45 weeks; body weight 2.9 ± 0.9, range 0.65-4.6 kg), the mean infusion rate was 10.4 ± 3.2 (range 4.5-19.6) ml·kg(-1) ·h(-1) BS-G1. During the infusion, hemoglobin, hematocrit, bicarbonate, base excess, anion gap, strong ion difference, and calcium decreased, and chloride and glucose increased significantly within the physiological range. All other measured parameters including sodium and lactate remained stable. Neither hypoglycemia (glucose < 3 mm) nor hyperglycemia (glucose > 10 mm) was documented after BS-G1 infusion. No adverse drug reactions were reported.
  
  
  CONCLUSIONS
  The study shows that the intraoperative use of an isotonic balanced electrolyte solution with 1% glucose and a mean infusion rate of 10 ml·kg(-1) ·h(-1) helps to avoid acid-base dysbalance, hyponatraemia, hypoglycemia, ketoacidosis, and hyperglycemia in surgical neonates. A careful intraoperative monitoring and adaptation of the infusion rate as needed is crucial because the glucose and fluid requirements may vary widely between subjects.
authors.affiliation: Medizinische Hochschule Hannover, Klinik für Anästhesiologie und Intensivmedizin-OE 8050, Hannover, Germany. suempelmann.robert@mh-hannover.de
authors.forename: Robert
authors.initials: R
authors.lastname: Sümpelmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Mader
authors.forename: Nils
authors.initials: N
authors.lastname: Dennhardt
authors.forename: Lars
authors.initials: L
authors.lastname: Witt
authors.forename: Christoph
authors.initials: C
authors.lastname: Eich
authors.forename: Wilhelm A
authors.initials: WA
authors.lastname: Osthaus
mesh_terms: D000136:Acid-Base Equilibrium / Q000502:physiology; D000758:Anesthesia; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000502:physiology; D004573:Electrolytes / Q000097:blood; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods*; D005865:Gestational Age; D005947:Glucose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007231:Infant, Newborn; D007430:Intraoperative Care / Q000379:methods*; D007552:Isotonic Solutions / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D016343:Monitoring, Intraoperative; D061214:Patient Safety; D011446:Prospective Studies; D018401:Sample Size
chemical_list: D001786:Blood Glucose; D004573:Electrolytes; D006454:Hemoglobins; D007552:Isotonic Solutions; D005947:Glucose