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Completed

NCT Number: NCT03955926

Ultrasonographic Assessment of Stomach 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.

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Key information

Conditions

General Anesthesia

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative oral carbohydrate loading

Dietary 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

Primary outcomes

  1. Cross-sectional area of gastric antrum

    Time frame: 1 hour before surgery

    Cross-sectional area of gastric antrum assessed by ultrasonography

Secondary outcomes

  1. Hunger score

    Time frame: 1 hour before surgery

    Hunger score is scored from 0 (never) to 10 (very much).

  2. Thirst score

    Time frame: 1 hour before surgery

    Thirst score is scored from 0 (never) to 10 (very much).

  3. Preoperative anxiety

    Time frame: 1 hour before surgery

    Preoperative anxiety is scored from 0 (never) to 10 (very much).

Sponsors and collaborators

Lead sponsor

Eunah Cho, MD

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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