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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohydrate group (Group OC) | Experimental | 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 |
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| Placebo group (Group OP) | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate group (Group OC) | Dietary Supplement | Carbohydrate group (Group OC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-15 score | Minimum value: 0, Maximum value: 150, higher scores mean better. | Postoperative 24th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-15 score | Minimum value: 0, Maximum value: 150, higher scores mean better. | preoperative, postoperative day 7 |
| Numerical Rating Scale | Range 0-10, 0=no pain, 10=the worse pain ever. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betül Başaran, MD,DESA | Karaman Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaman Training and Research Hospital | Karaman | 70200 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Placebo group (Group OP | Dietary Supplement | Placebo group (Group OP |
|
| 24 hours |
| Opioid consumption | Opioid consumption | 24 hours |
| Range of knee motion | Range of knee motion | 48 hours |
| Patient mobilization | Patient reporting time of first standing to the side of the bed and time up and go test 2 days | 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 | 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.) | 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 | One week after surgery |
| Glucose measurement | Glucose measurement | Postoperative 24th hour |