Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines
1 other identifier
interventional
64
1 country
1
Brief Summary
Oral carbohydrate loading until 2 h before surgery is well known to be effective in facilitating postoperative recovery and reducing complications, by maintaining homeostasis. However, there are still concerns in implementing this as a universal fasting guideline, because of the risk of pulmonary aspiration. Therefore, we designed this study to compare the two preoperative fasting guideline: (1) keep fasted from midnight until surgery, and (2) oral carbohydrate beverage 800 mL from midnight until 2 h before surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedMarch 4, 2020
March 1, 2020
7 months
May 17, 2019
March 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Cross-sectional area of gastric antrum
Cross-sectional area of gastric antrum assessed by ultrasonography
1 hour before surgery
Secondary Outcomes (3)
Hunger score
1 hour before surgery
Thirst score
1 hour before surgery
Preoperative anxiety
1 hour before surgery
Study Arms (2)
Control group
NO INTERVENTIONkept fasted from midnight until surgery
NO-NPO group
EXPERIMENTALdrink carbohydrate beverage until 2 h before surgery
Interventions
Carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg) 800 mL is given to the NO-NPO group until 2 hours before surgery
Eligibility Criteria
You may qualify if:
- adult aged from 18 to 70
- American Society of Anesthesiologists (ASA) class I or II
- absence of pregnancy
- not on lactation at the time of surgery
You may not qualify if:
- delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
- contraindicated to NSAID or opioid
- mental disorders
- alcoholism
- drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eunah Cho, MDlead
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Related Publications (1)
Cho EA, Huh J, Lee SH, Ryu KH, Shim JG, Cha YB, Kim MS, Song T. Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study. Anesth Analg. 2021 Sep 1;133(3):690-697. doi: 10.1213/ANE.0000000000005411.
PMID: 33591115DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Eunah Cho, M.D.
KangbukSamsung Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 20, 2019
Study Start
July 25, 2019
Primary Completion
February 10, 2020
Study Completion
February 10, 2020
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share