Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery

Sponsor
Istanbul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05734937
Collaborator
(none)
80
1
1
2.9
28

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: gastric assessment of gastric volume
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery: a Prospective Cohort Study
Anticipated Study Start Date :
Feb 17, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Gastric volume (ml/kg) [During the operation]

    Gastric volumes are going to be calculated

Secondary Outcome Measures

  1. The cross sectional area (ACSA) (preoperative)(mm2) [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) [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) [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 [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 [intraoperative]

    weighing sponge, pad, and blood volume in the aspirator

  6. duration of surgery [Intraoperative (throughout the surgical procedure)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University, Department of Anesthesiology Istanbul Fatih Turkey 34093

Sponsors and Collaborators

  • Istanbul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Demet Altun, Attending Anesthesiologist, Istanbul University
ClinicalTrials.gov Identifier:
NCT05734937
Other Study ID Numbers:
  • 2022/985
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023