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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04815070
Enrollment
40
Registered
2021-03-24
Start date
2021-03-29
Completion date
2022-03-07
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Arthritis

Brief 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.

Interventions

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.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Volume of Gastric ContentsLess than one hour prior to surgeryA full stomach is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.

Secondary

MeasureTime frameDescription
Numerical rating pain scaleOne hour prior to surgery, Postoperative 24 and 48 hourPostoperative pain score (0 = no pain, 10 = very severe pain)
Rescue analgesicsPostoperative 24 and 48 hourAmounts of the analgesics administered to manage the postoperative pain

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026