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

NCT05582356 | Completed

• 1 other identifier: 08-2023/06
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality Of Recovery

Keywords

Oral Carbohydrate; Elderly Patient; Mini Mental State Examination

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 score

  Minimum value: 0, Maximum value: 150, higher scores mean better.

  Postoperative 24th hour

Secondary Outcomes (9)

• Quality of Recovery-15 score

  preoperative, postoperative day 7

• Numerical Rating Scale

  24 hours

• Opioid consumption

  24 hours

• Range of knee motion

  48 hours

• Patient mobilization

  48 hours

Study Arms (2)

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

Dietary Supplement: Carbohydrate group (Group OC)

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.

Dietary Supplement: Placebo group (Group OP

Interventions

Carbohydrate group (Group OC) DIETARY_SUPPLEMENT

Carbohydrate group (Group OC)

Carbohydrate group (Group OC)

Placebo group (Group OP DIETARY_SUPPLEMENT

Placebo group (Group OP

Placebo group (Group OP)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Physical status according to the American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Betül Başaran, MD,DESA

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 20, 2023
• Primary Completion: March 4, 2024
• Study Completion: March 18, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-03

Locations

TU (1)