Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

NCT04815070 | Completed

• 1 other identifier: B-2103/673-307
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Numerical rating pain scale

  One hour prior to surgery, Postoperative 24 and 48 hour

• Rescue analgesics

  Postoperative 24 and 48 hour

Study Arms (2)

Diabetic

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

Non-Diabetic

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

Interventions

Ultrasonic measurement of antral area PROCEDURE

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.

Diabetic; Non-Diabetic

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring preoperative fasting period of at least 8 hours. 40 patients will be recruited in total. One cohort consisting 20 patients will be diabetic. The other cohort consisting of 20 patients will be non-diabetic.

You may qualify if:

• 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

You may not qualify if:

• Previous surgery of the upper gastrointestinal tract
• Achalasia

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 29, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)