About this trial
This study will investigate the impact of combining dexamethasone and bispectral index (BIS) monitoring on the incidence of postoperative nausea and vomiting, emergence delirium and recovery trajectories in children undergoing ear-nose-throat (ENT) surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
children aged 2 to 8 years undergoing endoscopic adenoidectomy
parental/child consent
ASA I-II (American Society of Anaesthesiologists Physical Status)
no central nervous system (CNS) or gastrointestinal tract (GIT) disease
Disqualifiers
Parent/child disapproval
ASA III and above (American Society of Anaesthesiologists Physical Status)
central nervous system (CNS) or gastrointestinal tract (GIT) disease
chronic corticosteroid therapy
Trial design
Parallel
Treatments tested in this trial
BIS monitoring
Procedure/SurgeryBIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Sham BIS monitoring
Procedure/SurgerySham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.
Treatment groups
Trial outcomes
Primary outcomes
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting within 24 hours after surgery under general anaesthesia. Vomiting is defined as the expulsion of gastric contents through the oral cavity. Nausea is defined for the purposes of this study using the Baxter Animated Retching Face (BARF) score of 4 or more.
Secondary outcomes
Effect of BIS monitoring on the incidence of emergent delirium
Effect of BIS monitoring on the incidence of emergent delirium (Paediatric Anaesthesia Emergence Delirium (PAED) above 10 and Watcha scale above 3) in the PACU.
Sponsors and contacts
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University Hospital Ostrava
Lead sponsor
Municipal Hospital Ostrava
Collaborator
Havířov Hospital
Collaborator
Frýdek-Místek Hospital
Collaborator
Tomas Bata Hospital, Czech Republic
Collaborator
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