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NCT Number: NCT07299435

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

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.

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

BIS monitoring

Procedure

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

Sham BIS monitoring

Procedure

Sham BIS monitoring will be used in this control group, the depth of anaesthesia will be guided by the values of minimum alveolar concentration.

Primary outcomes

  1. Effect of BIS monitoring on the incidence of postoperative nausea and vomiting

    Time frame: 24 hours

    Effect of BIS monitoring on the incidence of postoperative nausea and vomiting within 24 hours after surgery under general anaesthesia. Vomiting is defined as the expulsion of gastric contents through the oral cavity. Nausea is defined for the purposes of this study using the Baxter Animated Retching Face (BARF) score of 4 or more.

Secondary outcomes

  1. Effect of BIS monitoring on the incidence of emergent delirium

    Time frame: 1 hour from surgery

    Effect of BIS monitoring on the incidence of emergent delirium (Paediatric Anaesthesia Emergence Delirium (PAED) above 10 and Watcha scale above 3) in the PACU.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

+42059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Frýdek-Místek Hospital
  • Havířov Hospital
  • Municipal Hospital Ostrava
  • Tomas Bata Hospital, Czech Republic

Registry information

Official study 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)

Acronym: BISDEX

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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