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: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 8
Healthy Volunteers: f
View:
• Children aged 3-8 years
• ASA physical status class I-II
• Scheduled for elective adenoidectomy
• Written informed consent obtained from parents
Locations
Other Locations
Turkey
University of Health Sciences Kocaeli City Hospital
RECRUITING
Kocaeli
Contact Information
Primary
Engin Çetin
Doccetin52@gmail.com
532 120 60 04
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 58
Treatments
Active_comparator: BIS GROUP
BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60).
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Engin Çetin