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

March 19, 2021 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Non-randomized Comparative Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing total knee arthroplasty

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group C
Patients drank carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon A.
Other: Carbohydrate fluid
400 mL 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
0 mL carbohydrate fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric volume
Time Frame: During the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume measured before induction of spinal anesthesia using ultrasound
During the gastric volume measuring at preoperative holding area/ an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 16, 2020

Primary Completion (ACTUAL)

March 19, 2021

Study Completion (ACTUAL)

March 19, 2021

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • B-2008/633-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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