Quality Of RecoveryNCT05582356
Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty
A study testing Carbohydrate group (Group OC) in people with Quality Of Recovery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality Of Recovery
- What is being tested?
- Carbohydrate group (Group OC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Physical status according to the American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial
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.
Read the 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
- Conditions
- Quality Of Recovery
- Being tested
- Carbohydrate group (Group OC), Placebo group (Group OP
- Keywords
- Oral Carbohydrate, Elderly Patient, Mini Mental State Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate group (Group OC)Dietary supplement
Carbohydrate group (Group OC)
Placebo group (Group OPDietary supplement
Placebo group (Group OP
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Dietary Supplement: Placebo group (Group OP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Measured: Postoperative 24th hour
Secondary outcomes (9)
Quality of Recovery-15 score
Minimum value: 0, Maximum value: 150, higher scores mean better.
Measured: preoperative, postoperative day 7
Numerical Rating Scale
Range 0-10, 0=no pain, 10=the worse pain ever.
Measured: 24 hours
Opioid consumption
Opioid consumption
Measured: 24 hours
Range of knee motion
Range of knee motion
Measured: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed and time up and go test 2 days
Measured: 48 hours
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
Measured: preoperative
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.)
Measured: preoperative and postoperatve day 1
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
Measured: One week after surgery
Glucose measurement
Glucose measurement
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start20 Oct 2023
- Primary completion4 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality Of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betül Başaran, MD,DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582356
- Sponsor's protocol ID
- 08-2023/06
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2022
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05582356
- Acronym / sponsor ID
- 08-2023/06
- Conditions
- Quality Of Recovery
- Keywords
- Oral Carbohydrate, Elderly Patient, Mini Mental State Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate group (Group OC) | Experimental | Dietary Supplement: Carbohydrate group (Group OC)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 |
| Placebo group (Group OP) | Sham comparator | Dietary Supplement: Placebo group (Group OPPreoperative 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Physical status according to the American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for total knee arthroplasty
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate group (Group OC)Carbohydrate group (Group OC) | Dietary supplement | Carbohydrate group (Group OC) |
| Placebo group (Group OPPlacebo group (Group OP | Dietary supplement | Placebo group (Group OP) |
Primary outcome
Quality of Recovery-15 score
Time frame: Postoperative 24th hour
Minimum value: 0, Maximum value: 150, higher scores mean better.
9 secondary outcomes
Quality of Recovery-15 score
Time frame: preoperative, postoperative day 7
Numerical Rating Scale
Time frame: 24 hours
Opioid consumption
Time frame: 24 hours
Range of knee motion
Time frame: 48 hours
Patient mobilization
Time frame: 48 hours
Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission
Time frame: preoperative
Mini Mental State Examination
Time frame: preoperative and postoperatve day 1
Sleep Quality measured with Likert Scale
Time frame: One week after surgery
Glucose measurement
Time frame: Postoperative 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betül Başaran, MD,DESA study director
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate group (Group OC) in people with Quality Of Recovery, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 score (time frame: Postoperative 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.