Gastric Emptying Time of a Rice-based Meal

Gastric Emptying Time of a Rice-based Meal Using Serial Sonographic Assessment

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.

Study Overview

• Status: Unknown
• Conditions: Gastric Emptying
• Intervention / Treatment: Diagnostic test: ultrasonographic measurement of gastric antral cross-sectional area

Detailed Description

Aspiration of gastric contents into the lungs in surgical patients is a rare, but serious adverse event. Because a proper preoperative fasting is mandatory before anesthesia to prevent this severe complication, patients undergoing elective surgery have traditionally asked to fast overnight to ensure that their stomachs are empty. However, it is difficult and uncomfortable for patients not to eat or drink, particularly for those scheduled for surgery later in the day. Fasting may lead to thirst, hunger, anxiety, and tiredness, along with the potential for hypoglycemia and dehydration. Moreover, prolonged preoperative starvation triggers a metabolic response that precipitates gluconeogenesis and increases the organic response to trauma [7,8] and leads to delayed recovery after surgery. Avoiding inordinate fasting before surgery markedly reduces postoperative insulin resistance which has beneficial effects on postoperative glucose and protein metabolism.

Current guidelines by the American Society of Anesthesiologists (ASA) recommend a minimum of 6 hours after a light meal (toast and clear fluid) and 8 hours if the meal includes fried or fatty foods. In the era of evidence-based medicine, however, these fasting recommendations to keep a patient in preoperative fasting of 6-8 hours after the intake of solid meal are derived from survey opinions solicited from 470 active members of the ASA membership despite insufficient literature.

Recent studies have shown that real-time ultrasonography can provide reliable information about the nature (clear fluid, solid, or none) and volume of gastric content, being a non-invasive, inexpensive and safe method. The ultrasonographic measurement of antral cross-sectional area (CSA) is used for the assessment of gastric emptying in diabetic or dyspeptic patients and clinical investigations in obstetrical anesthesia. Thus, we designed this study to evaluate scientifically the gastric emptying time of solid meal using serial sonographic assessment in healthy volunteers. (Especially, there was no study to evaluate the gastric emptying time of a rice-based meal.) The objective of this study was to confirm or confront the minimum fasting time required for adequate gastric emptying for a rice-based meal (Asian foods), according to the suggestion of current guideline.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-746
    • Recruiting
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population is 10 healthy volunteers.

Description

Inclusion Criteria:

• age over 18 years old
• body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria:

• history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
• diabetes mellitus
• chronic kidney disease
• pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	2 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	3 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	4 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	5 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	6 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	7 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)	8 hours after the ingestion of a sold meal

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Principal Investigator: Taejong Song, MD, PhD, Kangbuk Samsung Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): December 27, 2018
• Study Completion (Anticipated): December 27, 2018

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KBSMC2018-08-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No