Skip to main content
Clinical Trials/NCT05582356
NCT05582356
Completed
Not Applicable

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

Karaman Training and Research Hospital1 site in 1 country84 target enrollmentOctober 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality Of Recovery
Sponsor
Karaman Training and Research Hospital
Enrollment
84
Locations
1
Primary Endpoint
Quality of Recovery-15 score
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
March 18, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karaman Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Quality of Recovery-15 score

Time Frame: Postoperative 24th hour

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

Secondary Outcomes

  • Quality of Recovery-15 score(preoperative, postoperative day 7)
  • Numerical Rating Scale(24 hours)
  • Opioid consumption(24 hours)
  • Patient mobilization(48 hours)
  • Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission(preoperative)
  • Sleep Quality measured with Likert Scale(One week after surgery)
  • Range of knee motion(48 hours)
  • Glucose measurement(Postoperative 24th hour)
  • Mini Mental State Examination(preoperative and postoperatve day 1)

Study Sites (1)

Loading locations...

Similar Trials