NCT04514380

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

August 12, 2020

Last Update Submit

March 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gastric volume

    Gastric volume measured before induction of spinal anesthesia using ultrasound

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

Study Arms (2)

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

400 mL carbohydrate fluid

Group C

0 mL carbohydrate fluid

Group N

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing total knee arthroplasty

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Hyo-Seok Na, MD., PhD.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 14, 2020

Study Start

September 16, 2020

Primary Completion

March 19, 2021

Study Completion

March 19, 2021

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations