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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04514380
Other study ID # B-2008/633-301
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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