Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines

NCT ID: NCT03955926

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2020-02-10

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.

Conditions

General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

kept fasted from midnight until surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

NO-NPO group

drink carbohydrate beverage until 2 h before surgery

Group Type: EXPERIMENTAL

preoperative oral carbohydrate loading

Intervention Type: 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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunah Cho, MD

OTHER

Sponsor Role: lead

Responsible Party

Eunah Cho, MD

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eunah Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

KangbukSamsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

References

Cho EA, Huh J, Lee SH, Ryu KH, Shim JG, Cha YB, Kim MS, Song T. Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study. Anesth Analg. 2021 Sep 1;133(3):690-697. doi: 10.1213/ANE.0000000000005411.

Reference Type: DERIVED

PMID: 33591115 (View on PubMed)

Other Identifiers

KBSMC IRB 2019-04-025-004

Identifier Type: -

Identifier Source: org_study_id