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KETOMED Study Protocol: Ketonemia and emergence delirium in a multicenter study
R Poves Álvarez1, E López-Santín2, B Martínez-Rafael3
1Servicio de Anestesiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; BioCritic. Group for Biomedical Research in Critical Care Medicine; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain; Departamento de Cirugía, Universidad de Valladolid, Valladolid, Spain; Instituto de Investigación Biosanitaria (IBioVall), Valladolid, Spain.
Insights
Preoperative ketonemia, a fasting-induced state, is being investigated as a potential cause of emergence delirium (ED) in children. The KETOMED study assesses if ketonemia independently predicts ED, aiming to improve paediatric anaesthetic recovery.
Area of Science:
- Anesthesiology
- Pediatric Medicine
- Metabolic Research
Background:
- Emergence delirium (ED) affects up to 33% of pediatric patients post-general anesthesia.
- Preoperative fasting's metabolic state, specifically ketonemia, is a potential contributor to ED but remains under-investigated.
- The KETOMED study explores ketonemia as an independent risk factor for pediatric ED.
Purpose of the Study:
- To determine if preoperative ketonemia is independently associated with the development of emergence delirium in pediatric patients.
- To investigate the role of ketonemia in the induction of ED.
- To provide evidence for implementing preoperative ketonemia screening.
Main Methods:
- A multicenter observational study involving pediatric patients undergoing general anesthesia.
- Patients will be categorized based on the presence or absence of ED, assessed using the validated Pediatric Anesthesia Emergence Delirium (PAED) scale.
- Key inclusion/exclusion criteria involve age, surgical type, and anesthesia protocols; primary outcome is ED's association with ketone levels.
Main Results:
- This section is to be filled upon study completion.
Conclusions:
- The KETOMED study addresses the under-researched role of ketone bodies in pediatric ED.
- Findings may guide clinical practice on fasting and fluid management to reduce ED incidence.
- The study aims to enhance the quality and safety of pediatric anesthetic recovery.
Introduction:
Emergence Delirium (ED) following general anaesthesia affects up to a third of paediatric patients. Its multifactorial aetiology suggests that the metabolic state derived from preoperative fasting plays a significant role. Ketonemia, a physiological state associated with 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 emergence delirium in the paediatric population.
Material And Methods:
Multicentre observational study in paediatric patients under general anaesthesia. Participants will be grouped based on the presence or absence of ED, defined using the Paediatric Anaesthesia Emergence Delirium (PAED) scale. Inclusion and exclusion criteria have been based on age, surgical type, and anaesthesia protocol. Main outcome will be ED and its association with ketone levels. Secondary outcomes include other clinical and sociodemographic risk factors and parental satisfaction.
Discussion:
Despite the number of studies showing the beneficial role of ketone bodies in cerebral development, little is known of their potential role in the induction of ED. KETOMED addresses this issue in a robust prospective study using 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.
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