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

Engin Çetin

Status: Completed

Conditions: PONV; BIS

Treatments: Diagnostic Test: CONTROL GROUP; Diagnostic Test: BIS GROUP

Study type: Interventional

Funder types: Other

Identifiers

NCT07189845

KSH-ANREA-EC-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 3-8 years
• ASA physical status class I-II
• Scheduled for elective adenoidectomy
• Written informed consent obtained from parents

Exclusion criteria

• Children with a previous history of PONV
• Patients receiving antiemetic, steroid, or sedative medication
• Acute upper respiratory tract infection
• History of neurological or psychiatric disorders
• Body mass index (BMI) below the 5th percentile or above the 95th percentile
• Anatomical airway abnormalities

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

58 participants in 2 patient groups

BIS GROUP

Active Comparator group

Description:

BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60).

Treatment:

Diagnostic Test: BIS GROUP

CONTROL GROUP

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: CONTROL GROUP