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NCT07889206
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Conditions: Tonsillectomy and Adenotonsillectomy in Children
Sex: All
Ages: 3 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
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.
Eligibility Criteria
Inclusion Criteria:
* Age 3-12 years.
* Elective tonsillectomy and/or adenotonsillectomy under general anesthesia.
* ASA physical status I-II.
* Written parental/legal guardian consent.
Exclusion Criteria:
* ASA physical status III or higher.
* Significant cardiac disease or arrhythmia.
* Anticipated difficult airway.
* Active upper respiratory tract infection.
* Inability to follow the standardized anesthesia protocol.
* Hemodynamic instability before mouth gag placement.
* Incomplete study data or protocol violation.
Source: ClinicalTrials.gov (NCT07889206). StuddyBuddy aggregates publicly available trial information.