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NCT Number: NCT07189845

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

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.

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Key information

Conditions

PONV BIS Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Kocaeli City Hospital

Kocaeli, Izmit, 41100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS GROUP

Diagnostic Test

In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.

Control group

Diagnostic Test

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.

Primary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.

    Time frame: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation

    PONV will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. The Postoperative nausea and vomiting (PONV) will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. PONV severity will be evaluated using a predefined four-point ordinal scale based on the presence and frequency of nausea and vomiting, as follows:

    0: No nausea or vomiting

    • Mild nausea
    • Severe nausea or a single vomiting episode
    • Severe nausea with multiple vomiting episodes or intractable PONV

Secondary outcomes

  1. Emergence Time

    Time frame: From discontinuation of sevoflurane at the end of surgery until eye opening in response to verbal command, assessed up to 30 minutes

    Emergence time (defined as the time from discontinuation of sevoflurane until the patient opens their eyes in response to verbal command)

  2. Antiemetic use and timing

    Time frame: 0-24 hours postoperatively

    The administration of rescue antiemetic drugs will be recorded for each patient within the first 24 hours after surgery. The specific agent used (e.g., ondansetron, dexamethasone), the time of administration, and the number of doses will be documented from anesthesia and nursing records. The outcome will be expressed as the proportion of patients requiring antiemetic medication and the mean time to first administration

Sponsors and collaborators

Lead sponsor

Engin Çetin

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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