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

NCT07299435 | Not Yet Recruiting

• 1 other identifier: FNO-KARIM-BISDEX
• Study Type: interventional
• Target: 1,508
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

postoperative nausea and vomiting; emergence delirium; children; ENT surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of BIS monitoring on the incidence of emergent delirium

  1 hour from surgery

Study Arms (2)

Intervention group - BIS monitoring

EXPERIMENTAL

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

Control group - sham BIS monitoring

EXPERIMENTAL

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

Interventions

BIS monitoring PROCEDURE

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

Intervention group - BIS monitoring

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.

Control group - sham BIS monitoring

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Municipal Hospital Ostrava: collaborator
• Havířov Hospital: collaborator
• Frýdek-Místek Hospital: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator

Study Sites (5)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Frýdek-Místek Hospital

Frýdek-Místek, 738 01, Czechia

Location

Havířov Hospital

Havířov, 736 01, Czechia

Location

Municipal Hospital Ostrava

Ostrava, 728 80, Czechia

Location

Tomáš Baťa Hospital, Zlín

Zlín, 762 75, Czechia

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Emergence Delirium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michal Frelich, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 23, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5)