Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Comparison of Fasting Gastric Volume Using Ultrasound in Diabetic and Non-Diabetic Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty: A Prospective Observational Study

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.

In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.

Study Overview

• Status: Completed
• Conditions: Degenerative Arthritis
• Intervention / Treatment: Procedure: Ultrasonic measurement of antral area

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

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

Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients will be recruited in total. One cohort consisting 20 patients will be diabetic. The other cohort consisting of 20 patients will be non-diabetic.

Description

Inclusion Criteria:

• Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
• American Society of Anestheiologist physical status classification 1, 2, and 3
• Body mass index < 35 kg/cm2

Exclusion Criteria:

• Previous surgery of the upper gastrointestinal tract
• Achalasia

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic; A group of diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.	Procedure: Ultrasonic measurement of antral area; Ultrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4. Antral area will correspond to the average of the three measures.
Non-Diabetic; A group of non-diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.	Procedure: Ultrasonic measurement of antral area; Ultrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4. Antral area will correspond to the average of the three measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of Gastric Contents	A "full stomach" is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.	Less than one hour prior to surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating pain scale	Postoperative pain score (0 = no pain, 10 = very severe pain)	One hour prior to surgery, Postoperative 24 and 48 hour
Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 24 and 48 hour

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): March 7, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: B-2103/673-307

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