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Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children
Sponsor: University Hospital Ostrava
Summary
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.
Official title: Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children: a Multicenter Prospective Double-blind Study (BISDEX TRIAL)
Key Details
Gender
All
Age Range
2 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
1508
Start Date
2026-01-05
Completion Date
2029-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
BIS monitoring
BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Sham BIS monitoring
Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.
Locations (5)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Frýdek-Místek Hospital
Frýdek-Místek, Czechia
Havířov Hospital
Havířov, Czechia
Municipal Hospital Ostrava
Ostrava, Czechia
Tomáš Baťa Hospital, Zlín
Zlín, Czechia