Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Degenerative Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04815070
• Other study ID #: B-2103/673-307
• Status: Completed
• Start date: March 29, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Arthritis
• Osteoarthritis

Intervention

Procedure:
• Ultrasonic measurement of antral area
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 ?/4. Antral area will correspond to the average of the three measures.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical rating pain scale	Postoperative pain score (0 = no pain, 10 = very severe pain)	One hour prior to surgery, Postoperative 24 and 48 hour
Secondary	Rescue analgesics	Amounts of the analgesics administered to manage the postoperative pain	Postoperative 24 and 48 hour