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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03017066
Other study ID # 1612100815
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2017
Est. completion date April 20, 2019

Study information

Verified date September 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date April 20, 2019
Est. primary completion date April 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Years
Eligibility Inclusion Criteria:

- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia

Exclusion Criteria:

- History of surgery on the esophagus or stomach

- History of gastrointestinal disease

- Ambulatory surgery

- Considered inappropriate by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound
Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.
Other:
General anesthesia
Scheduled operation under general anesthesia

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. — View Citation

Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48. — View Citation

Brady M, Kinn S, Ness V, O'Rourke K, Randhawa N, Stuart P. Preoperative fasting for preventing perioperative complications in children. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD005285. doi: 10.1002/14651858.CD005285.pub2. Review. — View Citation

Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21. — View Citation

Fukunaga C, Sugita M, Yamamoto T. Validity of ultrasonographic measurement of gastric volume in fasted pediatric patients without sedation. J Anesth. 2016 Oct;30(5):900-3. doi: 10.1007/s00540-016-2204-3. Epub 2016 Jun 22. — View Citation

Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250. — View Citation

Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intra-group difference between gastric volume measured on second and third ultrasound assessment Interval between second and third ultrasound assessment, an expected average of 1 hour
Secondary Inter-group difference in gastric volume at each time point From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours
Secondary Perioperative incidence of nausea, vomiting, fever, and respiratory complications From the induction of general anesthesia until postoperative 24 hours
Secondary Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
Secondary Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours
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