Effect of Oral Glucose Water Administration 1 Hour Preoperatively in Children with Cyanotic Congenital Heart Disease: A Randomized Controlled Trial

Abstract

Background Guidelines recommend a clear liquid fasting time of 2 h before surgery, which is often exceeded, leading to adverse reactions (ARs) such as discomfort, thirst, and dehydration. We assessed the gastric contents and ARs after oral glucose water administration 1 h prior to surgery in children with cyanotic congenital heart disease (CCHD). Material/Methods This was a non-inferiority randomized controlled trial of children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive oral glucose water (10 g of glucose in 100 ml of warm water, 5 ml/kg) 2 h (2-h group, n=174) or 1 h (1-h group, n=170) before surgery. The primary endpoint was gastric volume. Secondary endpoints included pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia. Pre- and intraoperative ARs were recorded. Results The 1-h group showed smaller gastric content volumes (0.34±0.35 (95% CI: 0.29–0.39) vs. 0.43±0.33 (95% CI: 0.38–0.48) ml/kg, t =2.55, P <0.05) and higher blood glucose (6.21±0.78 (95% CI: 6.09–6.33) vs. 5.59±1.11 (95% CI: 5.43–5.76) mmol/L, t =−5.91, P <0.001). The 95% confidence interval of the volume difference between the 2 groups was 0.017–0.163, the upper limit value was 0.163 <δ=0.2 ( P <0.01). The non-inferiority hypothesis was correct. The 1-h group showed lower incidence of crying, thirst and hypoxia (all P <0.05 vs. 2-h group). There were no differences in ARs between the 2 groups. Conclusions A 1-h fast prior to surgery was not inferior to a 2-h fast in terms of gastric residuals and ARs in pediatric patients with CCHD. Clinical trial registration: http://www.chictr.org.cn/showprojen.aspx?proj=9563 Registration number: ChiCTR-IPR-14005270

2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration—A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting *

“…Differences were not detected in vomiting 99,100 or gastric pH 99 between children fasted 1 h versus 2 h (low and very low strength of evidence, respectively). Discordant results for residual gastric volume were reported in two trials 99,100 randomizing patients to 1-and 2-h fasting. Six additional studies provided data on gastric volume over time.…”

“…Evidence concerning patientreported outcomes comparing 1-to 2-h clear liquid fasting in children was limited to one or two studies per outcome. Differences were not detected in preoperative hunger 99 (very low strength of evidence), preoperative thirst 99,100 (very low strength of evidence), or preoperative nausea 99 (very low strength of evidence). A single randomized controlled trial reported higher satisfaction in parents of children with a 1-h clear liquid fast compared with parents of children with a 2-h clear liquid fast 99 (very low strength of evidence).…”

“…99 The other trial included children undergoing surgery for cyanotic congenital heart disease and did not detect a difference in aspiration; however, incidence was high in this population (1.8 and 1.7% in the 1-and 2-h arms respectively). 100 A large prospective cohort study that included subgroups of children fasting less than 1 h (n = 1,709) and 1 to 2 h (n = 2,897) reported higher rates of aspiration and regurgitation in the less than 1-h fasting group (very low strength of evidence) but also noninferiority for regurgitation or pulmonary aspiration (not worse than 1 per 1,000) for a 1-to 2-h clear liquid fast compared with longer times. 101 Copyright © 2022, the American Society of Anesthesiologists.…”

“…The body of evidence included 9 studies (5 randomized controlled trials, 99,100,102,104,106 1 crossover study, 35 and 3 prospective cohort studies 101,103,105 ) providing data on 1- and 2-h fasting in pediatric patients. Only 2 of the trials randomized participants into 1- and 2-h fasting protocols; the remaining studies were not designed to compare 1- and 2-h fasting; however, they included results from pediatric patients fasted less than 2 h.…”

“…Two randomized controlled trials and one large prospective cohort study reported on aspiration and regurgitation. [99][100][101] One trial reported no aspiration in either group. 99 The other trial included children undergoing surgery for cyanotic congenital heart disease and did not detect a difference in aspiration; however, incidence was high in this population (1.8 and 1.7% in the 1-and 2-h arms respectively).…”