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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04514380

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fasting	Other: Carbohydrate fluid Other: Non-carbohydrate fluid

Study Design

Study Type:

Observational

Actual Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 16, 2020

Actual Primary Completion Date :

Mar 19, 2021

Actual Study Completion Date :

Mar 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group C Patients drank carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon A.	Other: Carbohydrate fluid 400 mL carbohydrate fluid
Group N Patients did not drink carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon B.	Other: Non-carbohydrate fluid 0 mL carbohydrate fluid

Arm

Intervention/Treatment

Group C

Patients drank carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon A.

Other: Carbohydrate fluid

400 mL carbohydrate fluid

Group N

Patients did not drink carbohydrate fluid 2 hours prior to surgery according to the routine fasting protocol by surgeon B.

Other: Non-carbohydrate fluid

0 mL carbohydrate fluid

Outcome Measures

Primary Outcome Measures

Gastric volume [During the gastric volume measuring at preoperative holding area/ an average of 30 minutes]
Gastric volume measured before induction of spinal anesthesia using ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator: Hyo-Seok Na, MD., PhD., Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo-Seok Na, Professor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT04514380

Other Study ID Numbers:

B-2008/633-301

First Posted:

Aug 14, 2020

Last Update Posted:

Mar 22, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2021