An interventional study of BIS GROUP and CONTROL GROUP in PONV and BIS, sponsored by Engin Çetin. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Engin Çetin · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60).
Diagnostic Test: BIS 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
Diagnostic Test: CONTROL GROUP
In the BIS group, monitoring will be visible and anesthesia depth will be maintained within a BIS value range of 40-60.
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.
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.
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 1. Mild nausea 2. Severe nausea or a single vomiting episode 3. Severe nausea with multiple vomiting episodes or intractable PONV
Time frame: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation
Emergence Time
Emergence time (defined as the time from discontinuation of sevoflurane until the patient opens their eyes in response to verbal command)
Time frame: From discontinuation of sevoflurane at the end of surgery until eye opening in response to verbal command, assessed up to 30 minutes
Antiemetic use and timing
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
Time frame: 0-24 hours postoperatively
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Postoperative Nausea and Vomiting→
Engin Çetin