The Effect of Stress on the Residual Gastric Volume

The Effect of Stress on the Residual Gastric Volume in Older Adults Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Study

In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.

In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.

Study Overview

• Status: Recruiting
• Conditions: Arthritis Knee
• Intervention / Treatment: Dietary supplement: Carbohydrate drinking

• Study Type: Observational
• Enrollment (Anticipated): 53

Contacts and Locations

• Study Contact: Name: Hyun-Jung Shin, MD., PhD.; Phone Number: 82317877508; Email: hjshin.anesth@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Hyun-Jung Shin, MD., PhD.; Email: hjshin.anesth@gmail.com
      • Principal Investigator: Hyo-Seok Na, MD., PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be patients who are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.

Description

Inclusion Criteria:

• Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
• American Society of Anesthesiologists physical status classification 1, 2, and 3
• Body mass index < 35 kg/cm2
• Patients administered carbohydrate-containing fluid 2 hours prior to surgery

Exclusion Criteria:

• Previous surgery of the upper gastrointestinal tract
• Achalasia
• Diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group C; Patients drank carbohydrate fluid 2 hours prior to surgery.	Dietary supplement: Carbohydrate drinking; Administration of carbohydrate fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of stress hormone 1	Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia	After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes
Level of stress hormone 2	Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia	After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric volume 1	Gastric volume measured before induction of spinal anesthesia using ultrasound	First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Gastric volume 2	Gastric volume measured before induction of spinal anesthesia using ultrasound	Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Anxiety scale 1	Anxiety scale measured before surgery	First stage operation, one day before surgery/ an average of 30 minutes
Anxiety scale 2	Anxiety scale measured before surgery	Second stage operation, one day before surgery/ an average of 30 minutes

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: B-2206-761-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No