Tonsillectomy and Adenotonsillectomy in ChildrenNCT07889206

Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery

A study testing Early Boyle-Davis Mouth Gag Placement and Delayed Boyle-Davis Mouth Gag Placement in people with Tonsillectomy and Adenotonsillectomy in Children, run by Yahyali State Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 3 to 12 years
Conditions the study is for: Tonsillectomy and Adenotonsillectomy in Children
What is being tested?: Early Boyle-Davis Mouth Gag Placement and Delayed Boyle-Davis Mouth Gag Placement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: 20 Oct 2026to 25 Feb 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age 3-12 years.
Elective tonsillectomy and/or adenotonsillectomy under general anesthesia.
ASA physical status I-II.
Written parental/legal guardian consent.

Who cannot join

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.

About this study

Official title: Effect of Boyle-Davis Mouth Gag Placement Timing on Hemodynamic Response in Pediatric Tonsillectomy and Adenotonsillectomy: A Randomized Controlled Trial

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.

Read the detailed description

This study will investigate whether the interval between endotracheal intubation and Boyle-Davis mouth gag placement influences the cardiovascular response to mouth gag insertion during pediatric tonsil surgery.

All participants will receive a standardized general anesthetic technique. Anesthesia will be induced with intravenous propofol 2 mg/kg, fentanyl 1 µg/kg, and rocuronium 0.6 mg/kg. Following endotracheal intubation, anesthesia will be maintained with sevoflurane in a 50% oxygen-50% nitrous oxide mixture. Age-adjusted minimum alveolar concentration will be targeted at 1.1 before mouth gag placement, and mechanical ventilation will be adjusted to maintain normocapnia.

Participants will be randomly allocated to early or delayed mouth gag placement. In the early-placement group, the Boyle-Davis mouth gag will be inserted 3 minutes after endotracheal intubation. In the delayed-placement group, it will be inserted 10 minutes after intubation.

No surgical stimulation will be initiated before mouth gag placement. Hemodynamic and respiratory variables will be recorded at predefined perioperative time points using standard intraoperative monitoring. Any clinically necessary treatment will take priority over the study protocol, and protocol deviations or additional medications administered before mouth gag placement will be documented.

Conditions: Tonsillectomy and Adenotonsillectomy in Children
Being tested: Early Boyle-Davis Mouth Gag Placement, Delayed Boyle-Davis Mouth Gag Placement
Keywords: Boyle-Davis Mouth Gag, Pediatric Tonsillectomy, Adenotonsillectomy, Heart Rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early Boyle-Davis Mouth Gag PlacementProcedure or surgery
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 PlacementProcedure or surgery
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.

Study groups in NCT07889206
Study group	Role	What they receive
Arm 1: Early Boyle-Davis Mouth Gag Placement	Experimental	Participants assigned to this arm will undergo Boyle-Davis mouth gag placement 3 minutes after endotracheal intubation under standardized general anesthesia. Receives: Procedure: Early Boyle-Davis Mouth Gag Placement
Delayed Boyle-Davis Mouth Gag Placement	Experimental	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. Receives: Procedure: Delayed Boyle-Davis Mouth Gag Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Heart Rate After Boyle-Davis Mouth Gag Placement (ΔHR%)
The primary outcome will be the percentage change in the maximum heart rate observed during the first 3 minutes after Boyle-Davis mouth gag placement relative to the heart rate measured immediately before mouth gag placement (ΔHR%).
Measured: before induction, immediately before Boyle-Davis mouth gag placement, and 1 and 3 minutes after mouth gag placement.

Secondary outcomes (4)

Change in Mean Arterial Pressure After Boyle-Davis Mouth Gag Placement
Mean arterial pressure was measured at the predefined time points and compared between the two study groups.
Measured: before induction, immediately before Boyle-Davis mouth gag placement, and 1 and 3 minutes after mouth gag placement.
Change in Systolic Arterial Blood Pressure After Boyle-Davis Mouth Gag Placement
Systolic arterial blood pressure was measured at the predefined time points and compared between the two study groups.
Measured: before induction, immediately before Boyle-Davis mouth gag placement, and 1 and 3 minutes after mouth gag placement.
Change in Diastolic Arterial Blood Pressure After Boyle-Davis Mouth Gag Placement
Diastolic arterial blood pressure was measured at the predefined time points and compared between the two study groups.
Measured: before induction, immediately before Boyle-Davis mouth gag placement, and 1 and 3 minutes after mouth gag placement.
Maximum Heart Rate After Boyle-Davis Mouth Gag Placement
The maximum heart rate was measured during the first 3 minutes after mouth gag placement and compared between the two study groups.
Measured: before induction, immediately before Boyle-Davis mouth gag placement, and 1 and 3 minutes after mouth gag placement.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202625 Feb 2027

First posted22 Oct 2026
Study start20 Oct 2026 (estimated)
Primary completion15 Feb 2027 (estimated)
Study completion25 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tonsillectomy and Adenotonsillectomy in ChildrenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07889206
Sponsor's protocol ID: Burcu
Status last verified: Oct 2026
First submitted: 15 Oct 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No