Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines

March 3, 2020 updated by: Eunah Cho, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
kept fasted from midnight until surgery
Experimental: NO-NPO group
drink carbohydrate beverage until 2 h before surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-sectional area of gastric antrum
Time Frame: 1 hour before surgery
Cross-sectional area of gastric antrum assessed by ultrasonography
1 hour before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hunger score
Time Frame: 1 hour before surgery
Hunger score is scored from 0 (never) to 10 (very much).
1 hour before surgery
Thirst score
Time Frame: 1 hour before surgery
Thirst score is scored from 0 (never) to 10 (very much).
1 hour before surgery
Preoperative anxiety
Time Frame: 1 hour before surgery
Preoperative anxiety is scored from 0 (never) to 10 (very much).
1 hour before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunah Cho, MD

Investigators

  • Principal Investigator: Eunah Cho, M.D., Kangbuksamsung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KBSMC IRB 2019-04-025-004

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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