Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

NCT ID: NCT04815070

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2022-03-07

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic

A group of diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.

Ultrasonic measurement of antral area

Intervention Type: 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.

Non-Diabetic

A group of non-diabetic patients who have fasted for at least 8 hours undergoing staged bilateral total knee arthroplasty.

Ultrasonic measurement of antral area

Intervention Type: 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.

Interventions

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 ㅠ/4.

Antral area will correspond to the average of the three measures.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyo-Seok Na

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-2103/673-307

Identifier Type: -

Identifier Source: org_study_id