Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty

Karaman Training and Research Hospital

Status: Completed

Conditions: Quality Of Recovery

Treatments: Dietary Supplement: Placebo group (Group OP; Dietary Supplement: Carbohydrate group (Group OC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05582356

08-2023/06

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Carbohydrate group (Group OC)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Carbohydrate group (Group OC)

Placebo group (Group OP)

Sham Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo group (Group OP