Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty
- Conditions
- Quality Of Recovery
- Interventions
- Dietary Supplement: Carbohydrate group (Group OC)Dietary Supplement: Placebo group (Group OP
- Registration Number
- NCT05582356
- Lead Sponsor
- Karaman Training and Research Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Physical status according to the American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbohydrate group (Group OC) 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 OC will consume carbohydrate fluid at 22.00 p.m. and two hours before the surgery Placebo group (Group OP) Placebo group (Group OP 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.
- Primary Outcome Measures
Name Time Method Quality of Recovery-15 score Postoperative 24th hour Minimum value: 0, Maximum value: 150, higher scores mean better.
- Secondary Outcome Measures
Name Time Method Patient mobilization 48 hours Patient reporting time of first standing to the side of the bed and time up and go test 2 days
Quality of Recovery-15 score preoperative, postoperative day 7 Minimum value: 0, Maximum value: 150, higher scores mean better.
Numerical Rating Scale 24 hours Range 0-10, 0=no pain, 10=the worse pain ever.
Opioid consumption 24 hours Opioid consumption
Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission preoperative 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Sleep Quality measured with Likert Scale 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
Range of knee motion 48 hours Range of knee motion
Glucose measurement Postoperative 24th hour Glucose measurement
Mini Mental State Examination 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.)
Trial Locations
- Locations (1)
Karaman Training and Research Hospital
🇹🇷Karaman, Turkey