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NCT Number: NCT04815070

Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

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.

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Key information

Conditions

Degenerative Arthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic measurement of antral area

Procedure

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.

Primary outcomes

  1. Volume of Gastric Contents

    Time frame: Less than one hour prior to surgery

    A "full stomach" is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.

Secondary outcomes

  1. Numerical rating pain scale

    Time frame: One hour prior to surgery, Postoperative 24 and 48 hour

    Postoperative pain score (0 = no pain, 10 = very severe pain)

  2. Rescue analgesics

    Time frame: Postoperative 24 and 48 hour

    Amounts of the analgesics administered to manage the postoperative pain

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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