Trials / Completed
CompletedNCT05734937
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery: a Prospective Cohort Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Istanbul University · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | gastric assessment of gastric volume | 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. |
Timeline
- Start date
- 2023-05-10
- Primary completion
- 2023-09-20
- Completion
- 2023-09-30
- First posted
- 2023-02-21
- Last updated
- 2023-10-03
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT05734937. Inclusion in this directory is not an endorsement.