Effect of BIS-Guided Anesthesia on Postoperative Nausea and Vomiting in Pediatric Patients (NCT07189845) | Clinical Trial Compass
CompletedNot Applicable
Effect of BIS-Guided Anesthesia on Postoperative Nausea and Vomiting in Pediatric Patients
Turkey (Türkiye)58 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range
3 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.
Timeframe: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation