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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-8
SponsorUniversity Hospital Ostrava

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BIS monitoring

    Procedure/Surgery

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

  • Sham BIS monitoring

    Procedure/Surgery

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

Treatment groups

1,508 Participants
are divided into 2 treatment groups
Group A: Intervention group - BIS monitoringExperimental treatment 1 intervention
Group B: Control group - sham BIS monitoringExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

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.

Time frame
1 hour from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

Municipal Hospital Ostrava

Collaborator

Havířov Hospital

Collaborator

Frýdek-Místek Hospital

Collaborator

Tomas Bata Hospital, Czech Republic

Collaborator

This trial is not recruiting at the moment. You can still explore other options: