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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tonsil Hypertrophy
• Intervention / Treatment: Procedure: BIS monitoring; Procedure: Sham BIS monitoring

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).

• Study Type: Interventional
• Enrollment (Estimated): 1508
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Frýdek-Místek, Czechia, 738 01
    • Frýdek-Místek Hospital
    • Contact: Kateřina Kusznírová, MD; Phone Number: 5111 +42055841; Email: info@nemfm.cz
    • Principal Investigator: Kusznírová, MD
  • Havířov, Czechia, 736 01
    • Havířov Hospital
    • Contact: Daniel Kmec, MD; Phone Number: 1111 +42059649; Email: sekretariat@nemhav.cz
    • Principal Investigator: Daniel Kmec, MD
  • Ostrava, Czechia, 728 80
    • Municipal Hospital Ostrava
    • Contact: Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA; Phone Number: 2555 +42059619; Email: martin.formanek@mnof.cz
    • Principal Investigator: Martin Formánek, Assoc.Prof.,MD,Ph.D.,MBA
  • Zlín, Czechia, 762 75
    • Tomáš Baťa Hospital, Zlín
    • Principal Investigator: Klára Nekvindová, MD
    • Contact: Klára Nekvindová, MD; Phone Number: 1111 +42057755; Email: podatelna@bnzlin.cz
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 +42059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Michal Frelich, MD, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group - BIS monitoring; 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.	Procedure: BIS monitoring; BIS monitoring will be used to guide the depth of anaesthesia in this intervention group.
Experimental: Control group - sham BIS monitoring; 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of BIS monitoring on the incidence of emergent delirium	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.	1 hour from surgery

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: Municipal Hospital Ostrava; Tomas Bata Hospital, Czech Republic; Frýdek-Místek Hospital; Havířov Hospital
• Investigators: Principal Investigator: Michal Frelich, MD, Ph.D., University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: children; emergence delirium; postoperative nausea and vomiting; ENT surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Postoperative Nausea and Vomiting
• Other Study ID Numbers: FNO-KARIM-BISDEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No