Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Completed

• Conditions: Degenerative Arthritis
• Interventions: Procedure: Ultrasonic measurement of antral area

• Registration Number: NCT04815070
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-03-29
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Diabetic	Ultrasonic measurement of antral area	A group of non-diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.
Diabetic	Ultrasonic measurement of antral area	A group of diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Volume of Gastric Contents	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of