Clinical trial NCT05734937: Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
Official title: Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Volume
Aspiration
Nausea
Bleeding
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric volume (ml/kg)
timeFrame: During the operation
Secondary outcomes:
measure: The cross sectional area (ACSA) (preoperative)(mm2)
timeFrame: preoperative
measure: The cross sectional area (ACSA) (after intubation)(mm2)
timeFrame: immediately after intubation
measure: The cross sectional area (ACSA) (postoperative)(mm2)
timeFrame: 10 minutes before extubation
measure: postoperative presence and severity of PONV
timeFrame: at the first, second and 24th hours in PACU and at the ward.
measure: blood volume in suction system
timeFrame: intraoperative
measure: duration of surgery
timeFrame: Intraoperative (throughout the surgical procedure)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
state: Fatih
Study officials:
affiliation: Istanbul University
name: Hilal Öztürk, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Demet Altun, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desgranges FP, Gagey Riegel AC, Aubergy C, de Queiroz Siqueira M, Chassard D, Bouvet L. Ultrasound assessment of gastric contents in children undergoing elective ear, nose and throat surgery: a prospective cohort study. Anaesthesia. 2017 Nov;72(11):1351-1356. doi: 10.1111/anae.14010. Epub 2017 Aug 14.
citation: Zhang G, Huang X, Shui Y, Luo C, Zhang L. Ultrasound to guide the individual medical decision by evaluating the gastric contents and risk of aspiration: A literature review. Asian J Surg. 2020 Dec;43(12):1142-1148. doi: 10.1016/j.asjsur.2020.02.008. Epub 2020 Mar 11.
citation: Bisinotto FM, Pansani PL, Silveira LA, Naves AA, Peixoto AC, Lima HM, Martins LB. Qualitative and quantitative ultrasound assessment of gastric content. Rev Assoc Med Bras (1992). 2017 Feb;63(2):134-141. doi: 10.1590/1806-9282.63.02.134.