Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty

NCT04814706 | Completed

• 1 other identifier: B-2103/673-302
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Group C

Patients drank carbohydrate fluid 2 hours prior to surgery.

Dietary Supplement: Carbohydrate drinking

Interventions

Carbohydrate drinking DIETARY_SUPPLEMENT

Administration of carbohydrate fluid

Group C

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.

You may qualify if:

• 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

You may not qualify if:

• Previous surgery of the upper gastrointestinal tract
• Achalasia
• Diabetes

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 30, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Locations

KR (1)