Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Dietary Supplement: preoperative oral carbohydrate loading

• Registration Number: NCT03955926
• Lead Sponsor: Eunah Cho, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-07-25
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO-NPO group	preoperative oral carbohydrate loading	drink carbohydrate beverage until 2 h before surgery

Primary Outcome Measures

Name	Time	Method
Cross-sectional area of gastric antrum	1 hour before surgery	Cross-sectional area of gastric antrum assessed by ultrasonography

Secondary Outcome Measures

Name	Time	Method
Hunger score	1 hour before surgery	Hunger score is scored from 0 (never) to 10 (very much).
Preoperative anxiety	1 hour before surgery	Preoperative anxiety is scored from 0 (never) to 10 (very much).
Thirst score	1 hour before surgery	Thirst score is scored from 0 (never) to 10 (very much).

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of