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

Quality Of Recovery Clinical Trial

Official title:

Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582356
• Other study ID #: 08-2023/06
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: March 18, 2024

Study information

• Verified date: March 2024
• Source: Karaman Training and Research Hospital
• Contact: Tayfun ET, MD
• Phone: +903382263000
• Email: drtayfunet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: March 18, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Quality Of Recovery

Intervention

Dietary Supplement:
• Carbohydrate group (Group OC)
Carbohydrate group (Group OC)
• Placebo group (Group OP
Placebo group (Group OP

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery-15 score	Minimum value: 0, Maximum value: 150, higher scores mean better.	Postoperative 24th hour
Secondary	Quality of Recovery-15 score	Minimum value: 0, Maximum value: 150, higher scores mean better.	preoperative, postoperative day 7
Secondary	Numerical Rating Scale	Range 0-10, 0=no pain, 10=the worse pain ever.	24 hours
Secondary	Opioid consumption	Opioid consumption	24 hours
Secondary	Range of knee motion	Range of knee motion	48 hours
Secondary	Patient mobilization	Patient reporting time of first standing to the side of the bed and time up and go test 2 days	48 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Glucose measurement	Glucose measurement	Postoperative 24th hour