Clinical trial NCT05582356: Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty
Official title: Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality Of Recovery
Keywords: Oral Carbohydrate
Elderly Patient
Mini Mental State Examination
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: Quality of Recovery-15 score
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Quality of Recovery-15 score
timeFrame: preoperative, postoperative day 7
measure: Numerical Rating Scale
timeFrame: 24 hours
measure: Opioid consumption
timeFrame: 24 hours
measure: Range of knee motion
timeFrame: 48 hours
measure: Patient mobilization
timeFrame: 48 hours
measure: Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission
timeFrame: preoperative
measure: Mini Mental State Examination
timeFrame: preoperative and postoperatve day 1
measure: Sleep Quality measured with Likert Scale
timeFrame: One week after surgery
measure: Glucose measurement
timeFrame: Postoperative 24th hour
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betül Başaran, MD,DESA
role: STUDY_DIRECTOR
References: