Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery

September 30, 2023 updated by: Demet Altun, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul University, Department of anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gastric assessment of gastric volume
ultrasound assessment of gastric volume in Preoperative and postoperative period in right lateral decubitus position in pediatric patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric volume (ml/kg)
Time Frame: During the operation
Gastric volumes are going to be calculated
During the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative
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
immediately after intubation
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
10 minutes before extubation
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)
at the first, second and 24th hours in PACU and at the ward.
blood volume in suction system
Time Frame: intraoperative
weighing sponge, pad, and blood volume in the aspirator
intraoperative
duration of surgery
Time Frame: Intraoperative (throughout the surgical procedure)
the time from the start of the surgery to the end of the surgery
Intraoperative (throughout the surgical procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Hilal Öztürk, Resident, Istanbul University
  • Principal Investigator: Demet Altun, Assoc. Prof, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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