Protocolo del estudio KETOMED: cetonemia y agitación al despertar en un estudio multicéntrico

Abstract

Introduction

Emergence delirium (ED) is a frequent complication in children following general anaesthesia, affecting up to a third of paediatric patients. Its multifactorial etiology suggests the metabolic state derived from preoperative fasting plays a significant role. Ketonemia, a physiological state subsequent to fasting, has been minimally investigated as an independent risk factor for ED. The KETOMED study aims to determine whether preoperative ketonemia is independently associated with the development of ED in the paediatric population.

Material and methods

Multicenter observational study, pediatric patients under general anesthesia. Participants will be grouped based on the presence or absence of ED, defined using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Inclusion and exclusion criteria were based on age, surgical type, and anaesthesia protocol. Main outcome will be ED and its association with ketonemia levels. Secondary outcomes included other clinical and sociodemographic risk factors and parental satisfaction.

Discussion

Although significant literature highlights the beneficial role of ketone bodies in cerebral development, a knowledge gap remains regarding their influence as a potentially adverse factor in the induction of ED. KETOMED addresses this through a robust prospective design and validated tools, including the Spanish translation of the PAED scale.

Conclusion

KETOMED is expected to establish evidence supporting the implementation of low-cost preoperative ketonemia screening. The results have the potential to guide clinical practice regarding fasting management and clear fluid administration, ultimately aiming to reduce the incidence of ED and improve the quality and safety of paediatric anaesthetic recovery.