An interventional study of Carbohydrate group (Group OC) and Placebo group (Group OP in Quality Of Recovery, sponsored by Karaman Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Karaman Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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
Karaman Training and Research Hospital is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. Group OC will consume carbohydrate fluid at 22.00 p.m. and two hours before the surgery
Dietary Supplement: Carbohydrate group (Group OC)
Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. Group OP will consume an equal amount of water 22:00 p.m. and two hours before the surgery.
Dietary Supplement: Placebo group (Group OP
Carbohydrate group (Group OC)
Placebo group (Group OP
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Time frame: Postoperative 24th hour
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Time frame: preoperative, postoperative day 7
Numerical Rating Scale
Range 0-10, 0=no pain, 10=the worse pain ever.
Time frame: 24 hours
Opioid consumption
Opioid consumption
Time frame: 24 hours
Range of knee motion
Range of knee motion
Time frame: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed and time up and go test 2 days
Time frame: 48 hours
Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission
5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Time frame: preoperative
Mini Mental State Examination
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.)
Time frame: preoperative and postoperatve day 1
Sleep Quality measured with Likert Scale
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
Time frame: One week after surgery
Glucose measurement
Glucose measurement
Time frame: Postoperative 24th hour
Ran from Oct 2023 to primary completion in Mar 2024, 4 months.
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Studies of the drug tested here: Carbohydrates
Karaman Training and Research Hospital