Quality Of Recovery
Conditions
Keywords
Oral Carbohydrate, Elderly Patient, Mini Mental State Examination
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
Interventions
DIETARY_SUPPLEMENTCarbohydrate group (Group OC)
Carbohydrate group (Group OC)
DIETARY_SUPPLEMENTPlacebo group (Group OP
Placebo group (Group OP
Sponsors
Karaman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 score | Postoperative 24th hour | Minimum value: 0, Maximum value: 150, higher scores mean better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | 24 hours | Range 0-10, 0=no pain, 10=the worse pain ever. |
| Opioid consumption | 24 hours | Opioid consumption |
| Range of knee motion | 48 hours | Range of knee motion |
| 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. |
| 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.) |
| 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 |
| Glucose measurement | Postoperative 24th hour | Glucose measurement |
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed