NCT07189845

Effect of BIS-Guided Anesthesia on Postoperative Nausea and Vomiting in Pediatric Patients

Effect of Bispectral Index (BIS)-Guided Anesthesia on Postoperative Nausea and Vomiting in Children Aged 3 to 8 Years: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Engin Çetin · Other Government
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3-8 years undergoing elective adenoidectomy. Fifty-eight patients will be randomized to BIS-guided anesthesia (target 40-60) or standard clinical management. The primary outcome is PONV incidence within 24 hours. Secondary outcomes include antiemetic use, emergence time, hospital stay, and parental satisfaction.

Detailed description

This prospective, randomized, double-blind controlled trial aims to evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3 to 8 years undergoing elective adenoidectomy. PONV is a common postoperative complication in pediatric surgery, with reported incidences of 30-70%, leading to delayed oral intake, prolonged hospital stay, and reduced parental satisfaction. BIS monitoring provides an objective EEG-based measure of anesthesia depth, allowing precise titration of anesthetic agents and potentially reducing postoperative complications. While adult studies and meta-analyses have shown that BIS guidance decreases the incidence of PONV, evidence in pediatric populations remains limited. A total of 58 ASA I-II patients will be randomized into two groups: BIS-guided anesthesia (target 40-60) and standard clinical parameter-guided anesthesia with the BIS screen hidden. The primary outcome is the incidence of PONV within 24 hours postoperatively. Secondary outcomes include antiemetic use, severity of PONV, time to emergence, length of hospital stay, and parental satisfaction assessed with a Likert scale. The findings of this trial are expected to clarify the role of BIS monitoring in improving postoperative outcomes in pediatric anesthesia.

Conditions

• PONV
• BIS

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	BIS GROUP	In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.
DIAGNOSTIC_TEST	CONTROL GROUP	In the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters.

Timeline

• Start date: 2025-09-24
• Primary completion: 2026-01-20
• Completion: 2026-01-20
• First posted: 2025-09-24
• Last updated: 2026-02-12

Locations

1 site across 1 country: Turkey (Türkiye)