NCT07299435

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

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,508 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Immediately after securing the airway, an electrode will be attached and BIS monitoring will begin. This will be used to control the depth of general anaesthesia throughout the entire surgical procedure, with the aim of achieving BIS values of 40-60. Intervention group: Following the administration of dexamethasone at the same dos-age as in the control group, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60. Control group: Once access to the vascular system has been secured, dexamethasone will be administered intravenously at a dose of 0.15 mg/kg body weight, up to a maxi-mum of 5 mg. A non-functional electrode for bispectral index (BIS) monitoring will then be attached to the patient's forehead. The depth of anaesthesia will be controlled based on the minimum alveolar concentration (target MAC: 1-1.1).

Conditions

• Tonsil Hypertrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-05
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

5 sites across 1 country: Czechia