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CompletedNCT04514380Updated Mar 22, 2021

Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients

An observational study in Fasting, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Seoul National University Bundang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
65 Years to 85 Years
Sex
All
01

Study summary

In the past, some guidelines advised no oral intake for at least 8 hours before any surgery. However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.

The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.

In our institution, there are two clinical pathways for total knee arthroplasty according to the surgeons. One difference is whether carbohydrate fluids drink or not before surgery. The purpose of this study, therefore, is to assess gastric volume in fasted elderly patients using ultrasound after they drank carbohydrate fluids 2 hours before surgery and to compare with matched patients using age, body mass index, and comorbidity, who did not drink carbohydrate fluids before surgery.

02

Conditions studied

  • Fasting
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In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing total knee arthroplasty

Inclusion criteria

  • Patients undergoing total knee arthroplasty
  • Age: 65\~85 yeas
  • ASA 1\~3

Exclusion criteria

Exclusion Criteria:

  • Age \< 65 years
  • ASA >= 4
  • Diabetes mellitus
  • Chronic kidney disease
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Group C

    Patients drank carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon A.

    Other: Carbohydrate fluid

  • Group N

    Patients did not drink carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon B.

    Other: Non-carbohydrate fluid

Interventions

  • OtherCarbohydrate fluid

    400 mL carbohydrate fluid

  • OtherNon-carbohydrate fluid

    0 mL carbohydrate fluid

06

What researchers measure

Primary outcomes

  1. Gastric volume

    Gastric volume measured before induction of spinal anesthesia using ultrasound

    Time frame: During the gastric volume measuring at preoperative holding area/ an average of 30 minutes

07

Study locations

1 site
  • Seoul National Univ. Bundang Hospital
    Seongnam, Gyeonggi 463-707, Korea, Republic of
08

References and documents

Publications

  • Shin HJ, Koo BW, Lim D, Na HS. Ultrasound assessment of gastric volume in older adults after drinking carbohydrate-containing fluids: a prospective, nonrandomized, and noninferiority comparative study. Can J Anaesth. 2022 Sep;69(9):1160-1166. doi: 10.1007/s12630-022-02262-9. Epub 2022 Apr 21. PubMed 35449247 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04514380
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Hyo-Seok Na (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Aug 14, 2020
Start date
Sep 16, 2020
Primary completion
Mar 19, 2021
Completion
Mar 19, 2021
Last update
Mar 22, 2021

Study contacts

Hyo-Seok Na, MD., PhD.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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