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Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery

I

Istanbul University

Status

Completed

Conditions

Nausea
Aspiration
Gastric Volume
Bleeding

Treatments

Other: gastric assessment of gastric volume

Study type

Interventional

Funder types

Other

Identifiers

NCT05734937
2022/985

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

1 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

gastric assessment of gastric volume
Experimental group
Description:
ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients
Treatment:
Other: gastric assessment of gastric volume

Trial contacts and locations

1

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Central trial contact

Demet Altun, Assoc. Prof.; Hilal Öztürk, Resident

Data sourced from clinicaltrials.gov

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