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NOT YET RECRUITING
NCT07299435
NA

Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children

Sponsor: University Hospital Ostrava

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

BIS monitoring

BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.

PROCEDURE

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