Effect of the Combination of Dexamethasone and BIS Monitoring on Reducing Postoperative Nausea and Vomiting in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BIS monitoring, Sham BIS monitoring.
- Who it may be relevant to
- Registry conditions: Tonsil Hypertrophy. Basic parameters: 2 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
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).
Interventions
- Procedure BIS monitoring
BIS monitoring will be used to guide the depth of anaesthesia in this intervention group. - 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.
Primary outcome measures
- Effect of BIS monitoring on the incidence of postoperative nausea and vomiting [Time frame: 24 hours]
Secondary outcome measures (1)
- Effect of BIS monitoring on the incidence of emergent delirium [Time frame: 1 hour from surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Czechia · 5 centers
- University Hospital Ostrava — Ostrava
- Frýdek-Místek Hospital — Frýdek-Místek
- Havířov Hospital — Havířov
- Municipal Hospital Ostrava — Ostrava
- Tomáš Baťa Hospital, Zlín — Zlín
Identifiers
NCT: NCT07299435 · FNO-KARIM-BISDEX