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Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Sponsor: Yahyali State Hospital
Summary
The aim of this randomized controlled trial is to compare the effects of placing the Boyle-Davis mouth gag 3 minutes versus 10 minutes after endotracheal intubation on the hemodynamic response in pediatric patients aged 3-12 years undergoing elective tonsillectomy and/or adenotonsillectomy. The Boyle-Davis mouth gag is routinely used in pediatric tonsil surgery to provide adequate surgical exposure. Mechanical stimulation of the oropharyngeal tissues during mouth gag placement may cause transient changes in heart rate and arterial blood pressure. At least 40 patients will be enrolled and randomized in a 1:1 ratio into two groups. In one group, the mouth gag will be placed 3 minutes after endotracheal intubation, whereas in the other group it will be placed 10 minutes after intubation. Anesthetic management will be standardized between the groups. Heart rate and arterial blood pressure will be recorded before induction, immediately before mouth gag placement, and at 1 and 3 minutes after placement. The maximum heart rate observed during the first 3 minutes after mouth gag placement will also be recorded. The primary outcome will be the percentage change in maximum post-gag heart rate relative to the pre-gag heart rate.
Official title: Effect of Boyle-Davis Mouth Gag Placement Timing on Hemodynamic Response in Pediatric Tonsillectomy and Adenotonsillectomy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10-20
Completion Date
2027-02-25
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Early Boyle-Davis Mouth Gag Placement
The Boyle-Davis mouth gag will be placed 3 minutes after successful endotracheal intubation. General anesthesia will be standardized with propofol 2 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg for induction, followed by sevoflurane and a 50% oxygen-50% nitrous oxide mixture for maintenance. Age-adjusted MAC will be targeted at 1.1 before mouth gag placement.
Delayed Boyle-Davis Mouth Gag Placement
The Boyle-Davis mouth gag will be placed 10 minutes after successful endotracheal intubation. General anesthesia will be standardized with propofol 2 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg for induction, followed by sevoflurane with a 50% oxygen-50% nitrous oxide mixture for maintenance. Age-adjusted MAC will be targeted at 1.1 before mouth gag placement.