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Ultrasound Assessment of Preoperative Gastric Volume in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017066
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Fasting Device: Ultrasound Other: General anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ultrasound Assessment of Gastric Volume Following Preoperative Fasting Guideline in Pediatric Patients
Actual Study Start Date : June 12, 2017
Actual Primary Completion Date : April 20, 2019
Actual Study Completion Date : April 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Infant formula
Patients were given infant formula 6 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
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

Experimental: Carbohydrate drink
Patients were given carbohydrate drink 2 hours prior to surgery. Gastric volume was assessed before ingestion, 1 hour prior to the surgery, and before the induction of general anesthesia using ultrasound.
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




Primary Outcome Measures :
  1. Intra-group difference between gastric volume measured on second and third ultrasound assessment [ Time Frame: Interval between second and third ultrasound assessment, an expected average of 1 hour ]

Secondary Outcome Measures :
  1. Inter-group difference in gastric volume at each time point [ Time Frame: From 6 hours prior to surgery to the induction of general anesthesia, an expected average of 6 hours ]
  2. Perioperative incidence of nausea, vomiting, fever, and respiratory complications [ Time Frame: From the induction of general anesthesia until postoperative 24 hours ]
  3. Degree of patient's preoperative anxiety, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  4. Degree of patient's preoperative hunger, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  5. Degree of patient's preoperative nausea, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  6. Degree of patient's preoperative thirst, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  7. Degree of patient's preoperative weakness, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  8. Degree of patient's preoperative irritability, scored from 0 to 10, with 0 being good and 10 being bad [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]
  9. Degree of parent's satisfaction, scored from 0 to 10, with 0 being satisfied and 10 being unsatisfied [ Time Frame: From 8 hours prior to surgery to the induction of general anesthesia, an expected average of 8 hours ]


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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017066


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim Seoul National University Hospital
Publications:

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Responsible Party: Jin-Tae Kim, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03017066    
Other Study ID Numbers: 1612100815
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
Ultrasonography
Child
Preoperative period
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs