Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery

Study Overview
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Brief Summary
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Adenoidectomy and/or tonsillectomy are performed for many reasons such as recurrent tonsil and adenoid infections, sleep apnea, symptomatic adenotonsillar hypertrophy, halitosis, peritonsillar abscess, and it is one of the most performed surgeries in the world. Passive blood loss from the surgical field into the gastric area may occur during the surgery. Investigators wonder whether the amount of blood and fluid accumulated in the stomach after tonsillectomy and/or adenoidectomy in children will increase the risk of aspiration. For this purpose, the aim is to compare the results with values considered risky for aspiration by evaluating the pre- and postoperative gastric volume with ultrasound in children who underwent elective adenoidectomy and /or tonsillectomy.

Detailed Description
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Tonsillectomy and/or adenoidectomy are performed for many reasons such as recurrent tonsil and adenoid infections, sleep apnea, symptomatic adenotonsillar hypertrophy, halitosis, peritonsillar abscess, and it is one of the most performed surgeries in the world. During these operations, there may be fluid and blood accumulation in the stomach. Investigators wonder whether the amount of blood and fluid accumulated in the stomach after tonsillectomy and/or adenoidectomy in children will increase the risk of aspiration. For this purpose, the aim is to compare the results with values considered risky for aspiration by evaluating the pre- and postoperative gastric volume with ultrasound in children who underwent tonsillectomy and/or adenoidectomy. This study will include ASA 1,2,3 patients under the age of 18 who will undergo tonsillectomy and/or adenoidectomy in the operating rooms of Istanbul University, Istanbul Medical Faculty, Department of Otorhinolaryngology, after the approval of the ethics committee. All the patients will be given oral midazolam at a dose of 0.3 mg/kg as standard in the preoperative preparation room. After standard monitoring (ECG, NIBP, SpO2) is performed in the operating room, gastric volume will be evaluated by ultrasound in the right lateral position before the operation. After induction of general anesthesia (sevoflurane + 02 + NO2 inhalation, 1 mcg/kg fentanyl, 0.5 mg/kg rocuronium) patients will be intubated. After intubation, gastric volume will be re-evaluated by ultrasound in the right lateral position. anesthesia will be maintained with a mixture of sevoflurane + 40%/60% O2/NO2 for a MAC of 1.0. At the end of the surgery, before the patient is extubated, the gastric volume will be evaluated by ultrasound in the right lateral position. Afterwards, the patients will be extubated and taken to the postoperative recovery room. Nausea and vomiting of patients during awakening and for the next 24 hours will be recorded. Patients' age, gender, height, weight, duration of surgery will also be recorded in the follow-up form.

Official Title
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Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery: a Prospective Cohort Study

Conditions
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Gastric Volume, Aspiration, Nausea, Bleeding

Intervention / Treatment
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* Other: gastric assessment of gastric volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing elective adenotonsillectomy surgery overnight fasting 1-18 years of age Accepting to the join the study American Society of Anesthesiology (ASA) classification I-II-III Exclusion Criteria: Age older than 18 years Preoperative vomiting or antiemetic medication therapy Intubation more than needing more than two laryngoscopy attempts Not given approval from the parents Disease or conditions affecting gastric volume or motility

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gastric assessment of gastric volume<br>ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients | Other: gastric assessment of gastric volume<br>* ultrasound assessment of gastric volume is going to bel evaluted in the Preoperative and postoperative period while the patients lay in right lateral decubitus position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume (ml/kg) | Gastric volumes are going to be calculated | During the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cross sectional area (ACSA) (preoperative)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | preoperative | 
| The cross sectional area (ACSA) (after intubation)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | immediately after intubation | 
| The cross sectional area (ACSA) (postoperative)(mm2) | measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4 | 10 minutes before extubation | 
| postoperative presence and severity of PONV | The severity of PONV was assessed according to the four points score : None (0 point) nausea (1 point) , nausea with maximum of two vomiting episodes (2 points) , more than two vomiting episodes (3 points) | at the first, second and 24th hours in PACU and at the ward. | 
| blood volume in suction system | weighing sponge, pad, and blood volume in the aspirator | intraoperative | 
| duration of surgery | the time from the start of the surgery to the end of the surgery | Intraoperative (throughout the surgical procedure) |