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Completed

NCT Number: NCT04814706

Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty

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.

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Key information

Conditions

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate drinking

Dietary Supplement

Administration of carbohydrate fluid

Primary outcomes

  1. Gastric volume 1

    Time frame: First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes

    Gastric volume measured before induction of spinal anesthesia using ultrasound

  2. Gastric volume 2

    Time frame: Second stage operative, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes

    Gastric volume measured before induction of spinal anesthesia using ultrasound

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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