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

NCT07299435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1508

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Tonsil Hypertrophy

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.

Sponsors & Collaborators

  • Municipal Hospital Ostrava

    collaborator OTHER

  • Havířov Hospital

    collaborator UNKNOWN

  • Frýdek-Místek Hospital

    collaborator UNKNOWN

  • Tomas Bata Hospital, Czech Republic

    collaborator OTHER

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Michal Frelich, MD, Ph.D. · University Hospital Ostrava

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07299435 on ClinicalTrials.gov