Clinical Trials Directory

Trials / Completed

CompletedNCT04815070

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Seoul National University Bundang Hospital · Academic / Other
Sex
All
Age
65 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasonic measurement of antral areaUltrasound 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.

Timeline

Start date
2021-03-29
Primary completion
2022-03-07
Completion
2022-03-07
First posted
2021-03-24
Last updated
2022-05-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04815070. Inclusion in this directory is not an endorsement.