Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Arthritis Knee Clinical Trial

Official title:

Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814706
• Other study ID #: B-2103/673-302
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: May 31, 2022

Study information

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

Clinical Trial Summary

In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.

The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.

Some factors have been known to 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, the investigators will evaluate the effect of old age, 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: 39
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• 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 Anesthesiologists physical status classification 1, 2, and 3

• Body mass index < 35 kg/cm2

• Patients administered carbohydrate-containing fluid 2 hours prior to surgery

Exclusion Criteria:

• Previous surgery of the upper gastrointestinal tract

• Achalasia

• Diabetes

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee

Intervention

Dietary Supplement:
• Carbohydrate drinking
Administration of carbohydrate fluid

Locations

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

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	Gastric volume 1	Gastric volume measured before induction of spinal anesthesia using ultrasound	First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes
Primary	Gastric volume 2	Gastric volume measured before induction of spinal anesthesia using ultrasound	Second stage operative, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes