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

Key facts

Who runs it
University Hospital Ostrava
Where
Czechia5 sites in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
1,508 people, planned
Started
5 Jan 2026
Expected to end
Jan 2029
Type of study
Interventional, 2 groups
Treatments tested
  • BIS monitoring
  • Sham BIS monitoring
Record updated
23 December 2025

Who can take part

Age
2 years to 8 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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
  • no corticosteroid medication

Who cannot take part

  • chronic corticosteroid therapy
  • central nervous system (CNS) or gastrointestinal tract (GIT) disease
  • Parent/child disapproval
  • ASA III and above (American Society of Anaesthesiologists Physical Status)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 8 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Intervention group - BIS monitoringTreatment being tested

    Following the administration of dexamethasone, BIS monitoring will be initiated immediately, with the depth of general anaesthesia controlled to a BIS value of 40-60.

    Treatment: BIS monitoring

  • Control group - sham BIS monitoringTreatment being tested

    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).

    Treatment: Sham BIS monitoring

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Fit questions
Built from NCT07299435, who can take part
Record updated
23 December 2025