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

University Hospital Ostrava

Status: Not yet enrolling

Conditions: Tonsil Hypertrophy

Treatments: Procedure: BIS monitoring; Procedure: Sham BIS monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07299435

FNO-KARIM-BISDEX

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,508 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,508 participants in 2 patient groups

Intervention group - BIS monitoring

Experimental group

Description:

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.

Treatment:

Procedure: BIS monitoring

Control group - sham BIS monitoring

Experimental group

Description:

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).

Treatment:

Procedure: Sham BIS monitoring