Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514380
• Other study ID #: B-2008/633-301
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• 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.

In our institution, there are two clinical pathways for total knee arthroplasty according to the surgeons. One difference is whether carbohydrate fluids drink or not before surgery. The purpose of this study, therefore, is to assess gastric volume in fasted elderly patients using ultrasound after they drank carbohydrate fluids 2 hours before surgery and to compare with matched patients using age, body mass index, and comorbidity, who did not drink carbohydrate fluids before surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients undergoing total knee arthroplasty

• Age: 65~85 yeas

• ASA 1~3

Exclusion Criteria:

• Age < 65 years

• ASA >= 4

• Diabetes mellitus

• Chronic kidney disease

Related Conditions & MeSH terms

• Fasting

Intervention

Other:
• Carbohydrate fluid
400 mL carbohydrate fluid
• Non-carbohydrate fluid
0 mL carbohydrate fluid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. 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	Gastric volume	Gastric volume measured before induction of spinal anesthesia using ultrasound	During the gastric volume measuring at preoperative holding area/ an average of 30 minutes