General AnesthesiaNCT03955926
Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines
A study testing preoperative oral carbohydrate loading in people with General Anesthesia, run by Eunah Cho, MD at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- General Anesthesia
- What is being tested?
- preoperative oral carbohydrate loading
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jul 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
- contraindicated to NSAID or opioid
- mental disorders
- alcoholism
- drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Stomach for Comparison of Antral Cross-sectional Area in Two Different Fasting Guidelines
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.
- Conditions
- General Anesthesia
- Being tested
- preoperative oral carbohydrate loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative oral carbohydrate loadingDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | kept fasted from midnight until surgery |
| NO-NPO group | Experimental | drink carbohydrate beverage until 2 h before surgery Receives: Dietary Supplement: preoperative oral carbohydrate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of gastric antrum
Cross-sectional area of gastric antrum assessed by ultrasonography
Measured: 1 hour before surgery
Secondary outcomes (3)
Hunger score
Hunger score is scored from 0 (never) to 10 (very much).
Measured: 1 hour before surgery
Thirst score
Thirst score is scored from 0 (never) to 10 (very much).
Measured: 1 hour before surgery
Preoperative anxiety
Preoperative anxiety is scored from 0 (never) to 10 (very much).
Measured: 1 hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start25 Jul 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
- Investigators
- Eunah Cho, M.D., Principal investigator, KangbukSamsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955926
- Sponsor's protocol ID
- KBSMC IRB 2019-04-025-004
- Status last verified
- Mar 2020
- First submitted
- 17 May 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33591115
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Stomach for Comparison of Antral Cross-sectional Area in Two Different Fasting Guidelines
- ClinicalTrials.gov ID
- NCT03955926
- Acronym / sponsor ID
- KBSMC IRB 2019-04-025-004
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –kept fasted from midnight until surgery |
| NO-NPO group | Experimental | Dietary Supplement: preoperative oral carbohydrate loadingdrink carbohydrate beverage until 2 h before surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
- contraindicated to NSAID or opioid
- mental disorders
- alcoholism
- drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative oral carbohydrate loadingCarbohydrate 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 | Dietary supplement | NO-NPO group |
Primary outcome
Cross-sectional area of gastric antrum
Time frame: 1 hour before surgery
Cross-sectional area of gastric antrum assessed by ultrasonography
3 secondary outcomes
Hunger score
Time frame: 1 hour before surgery
Thirst score
Time frame: 1 hour before surgery
Preoperative anxiety
Time frame: 1 hour before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 33591115Cho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eunah Cho, M.D. principal investigator
KangbukSamsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative oral carbohydrate loading in people with General Anesthesia, run by Eunah Cho, MD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area of gastric antrum (time frame: 1 hour before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.