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NCT03955926 Clinical Trial

Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines

General Anesthesia Clinical Trial

Official title:
Ultrasonographic Assessment of Stomach for Comparison of Antral Cross-sectional Area in Two Different Fasting Guidelines

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03955926
Other study ID # KBSMC IRB 2019-04-025-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2019
Est. completion date February 10, 2020

Study information
Verified date March 2020
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- delayed gastric emptying (GERD, gastrointestinal disease, diabetes)

- contraindicated to NSAID or opioid

- mental disorders

- alcoholism

- drug abuse

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• preoperative oral carbohydrate loading
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

Locations
Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Eunah Cho, MD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cross-sectional area of gastric antrum Cross-sectional area of gastric antrum assessed by ultrasonography 1 hour before surgery
Secondary Hunger score Hunger score is scored from 0 (never) to 10 (very much). 1 hour before surgery
Secondary Thirst score Thirst score is scored from 0 (never) to 10 (very much). 1 hour before surgery
Secondary Preoperative anxiety Preoperative anxiety is scored from 0 (never) to 10 (very much). 1 hour before surgery
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