Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Degenerative Arthritis

Intervention / Treatment
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* Procedure: Ultrasonic measurement of antral area


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic<br>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<br>* 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.<br>|
| Non-Diabetic<br>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<br>* 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.<br>|

What is the study measuring?
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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 |