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

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