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Completed

NCT Number: NCT05734937

Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gastric assessment of gastric volume

Other

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.

Primary outcomes

  1. Gastric volume (ml/kg)

    Time frame: During the operation

    Gastric volumes are going to be calculated

Secondary outcomes

  1. The cross sectional area (ACSA) (preoperative)(mm2)

    Time frame: preoperative

    measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4

  2. The cross sectional area (ACSA) (after intubation)(mm2)

    Time frame: immediately after intubation

    measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4

  3. The cross sectional area (ACSA) (postoperative)(mm2)

    Time frame: 10 minutes before extubation

    measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4

  4. postoperative presence and severity of PONV

    Time frame: at the first, second and 24th hours in PACU and at the ward.

    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)

  5. blood volume in suction system

    Time frame: intraoperative

    weighing sponge, pad, and blood volume in the aspirator

  6. duration of surgery

    Time frame: Intraoperative (throughout the surgical procedure)

    the time from the start of the surgery to the end of the surgery

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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