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NCT Number: NCT05582356

Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty

This prospective randomized controlled study will be aimed to evaluate the effect of preoperative oral carbohydrate loading on the elderly patient's quality of recovery and satisfaction in undergoing knee arthroplasty (TKA) surgery with spinal anesthesia.

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Key information

Conditions

Quality of Recovery

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

As an essential aspect of enhanced recovery after surgery, the advantages of preoperative oral carbohydrate loading (eg, improving patients' comfort during preoperative preparation, reducing nausea and vomiting, and reducing insulin resistance) have been shown by a large number of studies.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Elderly ( > 65) patients scheduled for elective TKA will be screened for enrollment in the study. Patients will be randomized into an oral carbohydrate group (Group OC), and an oral placebo group (Group OP). Solid food will be forbidden starting at 20:00, and drinking will be banned after 22:00 the day before surgery. Oral carbohydrate preload will be administered to the Group OC. In Group OP, the blinded researcher will give an equal volume of placebo fluid orally at 22:00 and 2 hours before the operation in the ward. The participant will record that the liquid has been completely consumed

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Physical status according to the American Society of Anesthesiologists (ASA) I-III
  • Patients scheduled for total knee arthroplasty

Exclusion criteria

  • Previous operation on same knee
  • Hepatic or renal insufficiency
  • Younger than 65 years old
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • ASA IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
  • impaired gastrointestinal motility
  • Fasting glucose >200
  • Acquired immunodeficiency
  • Severe malnutrition

Treatment and study plan

Carbohydrate group (Group OC)

Dietary Supplement

Carbohydrate group (Group OC)

Placebo group (Group OP

Dietary Supplement

Placebo group (Group OP

Primary outcomes

  1. Quality of Recovery-15 score

    Time frame: Postoperative 24th hour

    Minimum value: 0, Maximum value: 150, higher scores mean better.

Secondary outcomes

  1. Quality of Recovery-15 score

    Time frame: preoperative, postoperative day 7

    Minimum value: 0, Maximum value: 150, higher scores mean better.

  2. Numerical Rating Scale

    Time frame: 24 hours

    Range 0-10, 0=no pain, 10=the worse pain ever.

  3. Opioid consumption

    Time frame: 24 hours

    Opioid consumption

  4. Range of knee motion

    Time frame: 48 hours

    Range of knee motion

  5. Patient mobilization

    Time frame: 48 hours

    Patient reporting time of first standing to the side of the bed and time up and go test 2 days

  6. Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission

    Time frame: preoperative

    5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied

  7. Mini Mental State Examination

    Time frame: preoperative and postoperatve day 1

    Mini Mental State Examination Scale (This scale is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.)

  8. Sleep Quality measured with Likert Scale

    Time frame: One week after surgery

    Patients' perceived sleep quality will be assessed with a Likert scale. Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied

  9. Glucose measurement

    Time frame: Postoperative 24th hour

    Glucose measurement

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2022
Registry last updated
May 22, 2024

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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