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

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)

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07299435

Acronym

BISDEX

Enrollment

1508

Registered

2025-12-23

Start date

2026-01-05

Completion date

2029-01-31

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsil Hypertrophy

Keywords

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

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.

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

PROCEDUREBIS monitoring

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

PROCEDURESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 8 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Effect of BIS monitoring on the incidence of postoperative nausea and vomiting	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

Measure	Time frame	Description
Effect of BIS monitoring on the incidence of emergent delirium	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.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica

jiri.hyncica@fno.cz+42059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026