Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
Primary Purpose
Gastric Volume, Aspiration, Nausea
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
gastric assessment of gastric volume
Sponsored by
About this trial
This is an interventional other trial for Gastric Volume
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
Sites / Locations
- Istanbul University, Department of Anesthesiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gastric assessment of gastric volume
Arm Description
ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients
Outcomes
Primary Outcome Measures
Gastric volume (ml/kg)
Gastric volumes are going to be calculated
Secondary Outcome Measures
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
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
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
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)
blood volume in suction system
weighing sponge, pad, and blood volume in the aspirator
duration of surgery
the time from the start of the surgery to the end of the surgery
Full Information
NCT ID
NCT05734937
First Posted
January 20, 2023
Last Updated
September 30, 2023
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT05734937
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Volume, Aspiration, Nausea, Bleeding
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gastric assessment of gastric volume
Arm Type
Experimental
Arm Description
ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients
Intervention Type
Other
Intervention Name(s)
gastric assessment of gastric volume
Intervention Description
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 Outcome Measure Information:
Title
Gastric volume (ml/kg)
Description
Gastric volumes are going to be calculated
Time Frame
During the operation
Secondary Outcome Measure Information:
Title
The cross sectional area (ACSA) (preoperative)(mm2)
Description
measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4
Time Frame
preoperative
Title
The cross sectional area (ACSA) (after intubation)(mm2)
Description
measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4
Time Frame
immediately after intubation
Title
The cross sectional area (ACSA) (postoperative)(mm2)
Description
measurements are done with USG and calculated with this formula CSA=(AP(anterior -posterior) diameter x CC(craniotomy-caudal ) diameter x 3.14)/4
Time Frame
10 minutes before extubation
Title
postoperative presence and severity of PONV
Description
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)
Time Frame
at the first, second and 24th hours in PACU and at the ward.
Title
blood volume in suction system
Description
weighing sponge, pad, and blood volume in the aspirator
Time Frame
intraoperative
Title
duration of surgery
Description
the time from the start of the surgery to the end of the surgery
Time Frame
Intraoperative (throughout the surgical procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal Öztürk, Resident
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Demet Altun, Assoc. Prof
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Department of Anesthesiology
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
28805238
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.
Results Reference
background
PubMed Identifier
32171605
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.
Results Reference
background
PubMed Identifier
28355374
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.
Results Reference
background
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Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
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