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Trial registered on ANZCTR


Registration number
ACTRN12624000741583
Ethics application status
Approved
Date submitted
5/04/2024
Date registered
14/06/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Preoperative Fasting Period on Quality of Recovery in Elderly Patients undergoing Total Knee Arthroplasty
Scientific title
Effect of Preoperative Fasting Period on Quality of Recovery in Elderly Patients undergoing Total Knee Arthroplasty :a randomised controlled trial
Secondary ID [1] 311514 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative quality of recovery 332849 0
Total Knee Arthroplasty 332851 0
Condition category
Condition code
Anaesthesiology 329565 329565 0 0
Other anaesthesiology
Musculoskeletal 329567 329567 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will begin a fasting regime the day before surgery which will involve cessation of solid foods at 2000 hours and cessation of fluids at 2200hrs. All patients will be registered on the morning surgery list. All patients will be overseeing adherence to the fasting regime ward nurse. Strategies used to monitor adherence to the intervention include regular observation. This must be finished by 2200 hours and nursing staff will monitor fluid input. The intervention group will consume 300 ml liquid carbohydrates (100 ml solution includes 22.5 maltodextrin and 2.5 g glucose) up to three hours before surgery and will be monitored by nurses. The duration of time that participants will have to consume the liquid carbohydrates 10 minutes window.
Intervention code [1] 328511 0
Treatment: Other
Comparator / control treatment
The placebo group will begin a fasting regime the day before surgery which will involve cessation of solid foods at 2000 hours and cessation of fluids at 2200hrs. All patients will be registered on the morning surgery list. All patients will be overseeing adherence to the fasting regime ward nurse. Strategies used to monitor adherence to the intervention include regular observation. This must be finished by 2200 hours and nursing staff will monitor fluid input. The placebo group will consume equal amounts of water three hours before surgery and will be monitored by the nurse. The duration of time that participants will have to consume equal amounts of water 10 minutes window.
Control group
Placebo

Outcomes
Primary outcome [1] 337358 0
Quality of Recovery-15 score
Assessment method [1] 337358 0
QoR-15, a 15-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-10. The increase in scores shows the high quality of recovery. Minimum value: 0, Maximum value: 150, higher scores mean better.
Timepoint [1] 337358 0
24 hours after completion and closure of surgical procedure
Secondary outcome [1] 431562 0
Quality of Recovery-15 score
Assessment method [1] 431562 0
QoR-15, a 15-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-10. The increase in scores shows the high quality of recovery. Minimum value: 0, Maximum value: 150, higher scores mean better.
Timepoint [1] 431562 0
postoperative day 7
Secondary outcome [2] 431563 0
Numerical Pain Rating Scale
Assessment method [2] 431563 0
Range 0-10, 0=no pain, 10=the worse pain ever.
Timepoint [2] 431563 0
24 hours after completion and closure of surgical procedure
Secondary outcome [3] 431564 0
Opioid consumption
Assessment method [3] 431564 0
opioid consumption will be obtained by analysing medical records.
Timepoint [3] 431564 0
24 hours after completion and closure of surgical procedure
Secondary outcome [4] 431565 0
Range of knee motion
Assessment method [4] 431565 0
Range of knee motion via goniometer.
Timepoint [4] 431565 0
48 hours after completion and closure of surgical procedure
Secondary outcome [5] 431566 0
Time up and go test, Falls risk assessed via timed up and go test.
Assessment method [5] 431566 0
Patient reporting time of first standing to the side of the bed and time up and go test
Timepoint [5] 431566 0
Postoperative 2 days
Secondary outcome [6] 431568 0
Cognitive Impairment
Assessment method [6] 431568 0
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 normal cognition. Below this, scores can indicate severe (=9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment.)
Timepoint [6] 431568 0
preoperatively within 24 hours prior to the procedure and postoperative day 1
Secondary outcome [7] 431569 0
Sleep Quality measured with Likert Scale
Assessment method [7] 431569 0
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
Timepoint [7] 431569 0
One week after surgery
Secondary outcome [8] 431570 0
Glucose measurement
Assessment method [8] 431570 0
Glucose measurement via random finger-prick test
Timepoint [8] 431570 0
24 hours after completion and closure of surgical procedure.
Secondary outcome [9] 433446 0
Incidence of postoperative delirium (POD) within 1 day after surgery
Assessment method [9] 433446 0
Incidence of POD will be assessed at baseline and once daily within 1 day after surgery (3D-CAM) by anesthesiologist(s).
Timepoint [9] 433446 0
postoperative 1 day
Secondary outcome [10] 434716 0
Thirst
Assessment method [10] 434716 0
thirst; 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Timepoint [10] 434716 0
Before the operating room admission and postoperative 1 day
Secondary outcome [11] 434717 0
Hunger
Assessment method [11] 434717 0
Hunger; 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Timepoint [11] 434717 0
Before the operating room admission and postoperative 1 day
Secondary outcome [12] 434718 0
Mouth dryness
Assessment method [12] 434718 0
Mouth dryness; 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Timepoint [12] 434718 0
Before the operating room admission and postoperative 1 day
Secondary outcome [13] 434719 0
Nausea and vomiting
Assessment method [13] 434719 0
Nausea and vomiting; 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Timepoint [13] 434719 0
Before the operating room admission and postoperative 1 day
Secondary outcome [14] 434720 0
Fatigue
Assessment method [14] 434720 0
Fatigue; 5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied
Timepoint [14] 434720 0
Before the operating room admission and postoperative 1 day

Eligibility
Key inclusion criteria
Physical status according to the American Society of Anesthesiologists (ASA) II-III
Patients scheduled for total knee arthroplasty
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous operation on the 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2024
Actual
30/06/2024
Date of last participant enrolment
Anticipated
13/10/2024
Actual
Date of last data collection
Anticipated
20/10/2024
Actual
Sample size
Target
100
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 26143 0
Turkey
State/province [1] 26143 0
Karaman
Country [2] 26144 0
Turkey
State/province [2] 26144 0
Karaman

Funding & Sponsors
Funding source category [1] 315803 0
Hospital
Name [1] 315803 0
Karaman Training and Research Hospital
Country [1] 315803 0
Turkey
Primary sponsor type
Hospital
Name
Karaman Training and Research Hospital
Country
Turkey
Secondary sponsor category [1] 317928 0
None
Name [1] 317928 0
Country [1] 317928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314661 0
Karamanoglu Mehmetbey Üniversitesi Tip Fakültesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 314661 0
Ethics committee country [1] 314661 0
Turkey
Date submitted for ethics approval [1] 314661 0
11/08/2023
Approval date [1] 314661 0
13/09/2023
Ethics approval number [1] 314661 0
08-2023/06

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 132322 0
Dr Tayfun Et
Address 132322 0
Karaman Training and Research Hospital, Mh., 1984. Sk. No:1, 70200 Merkez/Karaman Merkez/Karaman, Türkiye.
Country 132322 0
Turkey
Phone 132322 0
+905063670717
Email 132322 0
drtayfunet@gmail.com
Contact person for public queries
Name 132323 0
Tayfun Et
Address 132323 0
Karaman Training and Research Hospital, Mh., 1984. Sk. No:1, 70200 Merkez/Karaman Merkez/Karaman, Türkiye.
Country 132323 0
Turkey
Phone 132323 0
+905063670717
Email 132323 0
drtayfunet@gmail.com
Contact person for scientific queries
Name 132324 0
Tayfun Et
Address 132324 0
Karaman Training and Research Hospital, Mh., 1984. Sk. No:1, 70200 Merkez/Karaman Merkez/Karaman, Türkiye.
Country 132324 0
Turkey
Phone 132324 0
+905063670717
Email 132324 0
drtayfunet@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.