AzTrials
AzTrials

Total Knee ArthroplastyEarly Phase 1NCT05603364

Effect of Postoperative Oral Carbohydrate Administration in Total Knee Arthroplasty Elderly Patients

A Early Phase 1 study testing 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose and Routine feeding in people with Total Knee Arthroplasty and Postoperative Oral Carbohydrates, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose and Routine feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteChina
Study dates
22 Nov 2022to 1 Jun 2023
Phase
Early Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients undergoing elective knee replacement surgery.
  • The patient gave informed consent.
  • Age ≥65 years, Sex is not limited
  • American Society of Anesthesiologists (ASA)Ⅰ~Ⅲ level
  • Body Mass Index (BMI)18~28kg/m2

Who cannot join

  • Preoperative gastric emptying disorders, such as gastroesophageal reflux or previous surgery.
  • Diabetes mellitus, severe renal insufficiency, or other severe metabolic diseases.
  • History of motion sickness.
  • Mental disorders, alcoholism, or a history of substance abuse.
  • Patients with abnormal swallowing function.
  • Maltodextrin, fructose allergy or intolerance.
  • Surgery time was greater than 3 hours.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

Other trials in China

About this study

To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients.

Read the detailed description

Most of the current clinical studies of oral carbohydrate effects on postoperative recovery focus on the preoperative oral phase, and only a few small samples have shown that postoperative oral carbohydrate improves postoperative comfort. Therefore, further systematic studies on the effects of early postoperative oral carbohydrates on postoperative recovery remain lacking.

This clinical study uses a single center, randomized, single-blind, parallel controlled trial design divided into screening, treatment and follow-up period.

Actively control blood pressure, blood pressure and blood sugar, correct anemia and hypoproteinemia, and increase protein intake before surgery. The dietary plan was informed by the ward nurse: all patients were fasted with solid food 6 hours before surgery and took 200 milliliters of carbohydrates orally 2-3 hours before surgery.

The venous access was open after home invasion and was routinely monitored electrocardiogram (ECG), non-invasive blood pressure (NBP) ,oxygen saturation (SpO2) ,bispectral index (BIS). Parecoxib 40 milligrams of analgesia was given intravenously at 30 minutes before the start of the procedure. Adductor canal block (ACB) and Infiltration between popliteal artery and capsule of knee (IPACK) block were performed on the lower limbs of the surgical side using an ultrasound high-frequency line array probe before induction of the general anesthesia procedure.

Anesthesia induction: after static injection of Midazolam 0.03 milligrams / kilogram, Propofol 2 milligrams / kilogram, Sufentanyl 0.4 milligrams / kilogram, Cisatracurium 0.2 milligrams / kilogram. The tracheal tube was inserted after 3minutes and mechanical controlled ventilation was performed mechanical controlled ventilation, fraction of inspired oxygen(FiO2) 40%, oxygen flow 2 liters/ minutes, minute ventilation 7 milliliters / kilogram, respiratory rate(RR)12 times/ inspiration-to-expiratory ratio(I: E)1:2, maintain partial pressure of carbon dioxide in end expiratory gas (PETCO2) 35-40 millimeters of mercury(mmHg). Anesthesia maintenance: intravenous propofol 4~7 milligrams / kilogram/ hour, remifentanil 0.3-0.5micrograms /kilogram/ hour, maintain BIS 40~60. A restrictive fluid management strategy was adopted, with 6ml/ kg·h supplemented with physiological needs, blood loss was supplemented with hydroxyethyl starch fluid, and concentrated red blood cells were infused at hemoglobin (Hb) <80 grams / litre to maintain patient blood pressure and heart rate fluctuations less than ±20% of the basal value. Dexamethasone 5mg and Tropisetron 2mg for prophylactic antiemesis were given intravenously at 30min before the end of the surgery. All patients used hydromorphone patient-controlled intravenous analgesia(PCIA ) pump for continuous: 1ml / h, automatic control: 5ml, locking: 10min, limit: 35ml / h, adjust parameters according to the pain.

Internal post anesthesia care unit (PACU) management: Patients will randomly enter the PACU into two study groups: early carbohydrate feeding group (EOF group) and conventional feeding group (control group). Routine feeding group (Group C): Patients in group C were observed with 60min of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 h, and began to eat gradually through the mouth after anal exhaust. Early carbohydrate feeding group (EOF group): The EOF group drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room. PACU management: Patients will randomly enter the PACU into two study groups: early carbohydrate feeding group (EOF group) and conventional feeding group (control group). Routine feeding group (Group C): Patients in group C were observed with 60min of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 h, and began to eat gradually through the mouth after anal exhaust. Early carbohydrate feeding group (EOF group): The EOF group drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.

To evaluate the drinking criteria for patients in the EOF group: Steward wake score of 6 and wake level 3, take 5 ml/kg body weight of 12.5% carbohydrate (100ml containing 12.5g maltodextrin, fructose, and glucose) according to the patient's consent. The process of drinking carbohydrates was to take 30ml orally first. After observing the swallowing without abnormality, the patient was ordered to drink the remaining drinks within 2h. After the patient returns to the ward, the liquid diet is gradually excessive to the normal diet. When the patient was able to tolerate the normal diet, v.

  1. Steward score: Awakening degree: 0-no response to stimulus; 1-some response to stimulus; 2-full awake.(2) Respiratory tract patency degree: 0 points-the patient's respiratory tract needs support; 1 points-the patient's respiratory tract can maintain patency without support; 2 points-the patient can cough according to the doctor's guidance.(3) Body activity degree: 1 points-the patient's limb has no activity; 2 points-the patient's limb has an unconscious activity; 3 points-the patient's limb can carry out conscious activities
  2. Wakefulness classification according to the patient's consciousness performance: Level 0: the patient is completely asleep, Call without any response; Level 1: The patient is falling asleep, However, head and neck movement, eye opening or limb movement when breathing; level 2: the patient is awake, Have the same performance as level 1, At the same time can also open the mouth, stretch the tongue; Level 3: The patient is awake, Have the same performance as level 2, At the same time can also clearly say their own name, age and other information; Level 4: The patient is awake, Have the same performance as level 3, It can also accurately identify the surrounding environment, And tell you exactly where you are.
  3. In addition to receiving different feeding treatment programs in the PACU, the two groups received the same care and diet program formulated by the same care group.

Record: Patients had fasting serum prealbumin, retinol-binding protein levels, and insulin resistance index on the same day, 1day and 3 days after surgery.

Record: 2 hours, 6 hours and 8 hours postoperative digital scores; bloating, hypoxemia and reflux aspiration occurred 24 hours after surgery.

Record: length of hospitalization, first anal exhaust time, first ambulation time, nausea and vomiting, and patient satisfaction.

Being tested
100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose, Routine feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucoseCombination product

    Drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.

  • Routine feedingOther

    Patients in group C were observed with 60min of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 h, and began to eat gradually through the mouth after anal exhaust

Study groups in NCT05603364
Study groupRoleWhat they receive
EOF group:early carbohydrate feedingExperimentalThe EOF group drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.
Receives: Combination Product: 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose
Control group:conventional feedingExperimentalPatients in group C were observed with 60minutes of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 hours, and began to eat gradually through the mouth after anal exhaust.
Receives: Other: Routine feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-albumin levels at fasting

    The change in prealbumin levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period

    Measured: 1 day after surgery

Secondary outcomes (16)
  1. Pre-albumin levels at fasting

    The change in prealbumin levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period

    Measured: On the day of the surgery

  2. Pre-albumin levels at fasting

    The change in prealbumin levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period

    Measured: 3 days after surgery

  3. Retinol-binding protein levels at fasting levels

    Changing the levels of early morning retinol-binding protein in venous blood in a fasting state can reflect whether carbohydrate administration is advantageous in the early postoperative period

    Measured: Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)

  4. Insulin resistance index at fasting

    In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period

    Measured: Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)

  5. The NRS score for the thirst condition

    Numerical Rating Scale (Numerical Rating Scale, NRS) was used to evaluate patients' thirst, according to a scale of 0 to 10 points: no thirst and 10 points: unbearable thirst. A lower NRS score for thirst conditions indicates that early carbohydrate postoperative administration is advantageous.

    Measured: 2 hours, 6 hours and 8 hours after surgery

  6. The NRS score for the starvation conditions

    Using the digital scoring method (Numerical Rating Scale, NRS) to assess patient hunger, according to the 0 to 10 scale: no hunger and 10: unbearable hunger. A lower NRS score for starvation conditions indicates that early carbohydrate postoperative administration is advantageous.

    Measured: 2 hours, 6 hours and 8 hours after surgery

  7. The degree of abdominal distension

    Using grading method, complaining of abdominal distention, tolerable, feeling gas rolling in the abdomen, no obvious abdominal signs, mild abdominal distension, abdominal distention, moderate abdominal distension, vomiting, dyspnea, and significant abdominal bulge.

    Measured: 24 hours after surgery

  8. Time of the first anal exhaust after surgery

    The advanced time of the first postoperative anal exhaust indicates a favorable early postoperative carbohydrate administration

    Measured: Up to 48 hours postoperative

  9. length of patient stays

    The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous

    Measured: Up to 7days postoperative

  10. Time of first ambulation after surgery

    The early time of the first postoperative ambulation indicates that early postoperative carbohydrate administration is advantageous

    Measured: Up to 48 hours postoperative

  11. The incidence of reflux aspiration

    The reduced incidence of reflux aspiration indicates that early postoperative carbohydrate administration is advantageous

    Measured: 24 hours after surgery

  12. The incidence rate of hypoxemia

    The reduced incidence of hypoxemia suggests that early postoperative carbohydrate administration is advantageous

    Measured: 24 hours after surgery

  13. Patient satisfaction score

    Rated on a 0-10 scale, with a higher score representing greater satisfaction.

    Measured: Up to 48 hours postoperative

  14. The incidence and severity of various adverse events (AE) from the start of oral carbohydrates until the end of the trial

    The lower the incidence and severity of various adverse events (AE) from the start of postoperative oral carbohydrates until the end of the trial, it indicates that the early postoperative carbohydrate administration is beneficial

    Measured: Up to 48 hours postoperative

  15. The incidence and severity of adverse events such as nausea, vomiting and hypoxemia from the first start of drug administration until the end of the trial;

    The lower the incidence and severity of adverse events such as nausea, vomiting, and hypoxemia until the end of the trial with the initial drug administration indicates that the early postoperative carbohydrate administration is advantageous

    Measured: Up to 48 hours postoperative

  16. Number of antiemetic drugs used within 24h of initial administration until the first start of administration

    The less use of antiemetic drugs within 24h after the first start of postoperative administration indicates that early postoperative carbohydrate administration is advantageous

    Measured: Up to 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2022
  2. Study start22 Nov 2022
  3. Primary completion1 Jun 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05603364
Sponsor's protocol ID
Nanjing First Hospital Han Liu
Status last verified
Oct 2022
First submitted
16 Oct 2022
Last updated
1 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Miller TE, Roche AM, Mythen M. Fluid management and goal-directed therapy as an adjunct to Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):158-68. doi: 10.1007/s12630-014-0266-y. Epub 2014 Nov 13.

    PubMed 25391735
  • Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15.

    PubMed 31309323
  • Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.

    PubMed 25827282
  • [4] Surgery Branch of Chinese Medical Association, Anesthesiology Branch of Chinese Medical Society. Chinese Expert Consensus and Path Management Guidelines for Accelerating Rehabilitation Surgery (2018) [J]. Chinese Journal of Anesthesiology, 2018,38 (001): 8-13.

  • Yang R, Tao W, Chen YY, Zhang BH, Tang JM, Zhong S, Chen XX. Enhanced recovery after surgery programs versus traditional perioperative care in laparoscopic hepatectomy: A meta-analysis. Int J Surg. 2016 Dec;36(Pt A):274-282. doi: 10.1016/j.ijsu.2016.11.017. Epub 2016 Nov 10.

    PubMed 27840308
  • [6] Bethune Orthopaedic Accelerated Rehabilitation Alliance, Bethune Charity Foundation Orthopaedic Professional Committee of trauma, Joint Surgery Professional Committee of Bethune Charity Foundation, etc. Guidelines for the management of perioperative fasting fasting in orthopaedic surgery [J]. Chinese Journal of Trauma and Orthopedics, 2019,21 (10): 829-834.

  • Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.

    PubMed 25121931
  • Noba L, Wakefield A. Are carbohydrate drinks more effective than preoperative fasting: A systematic review of randomised controlled trials. J Clin Nurs. 2019 Sep;28(17-18):3096-3116. doi: 10.1111/jocn.14919. Epub 2019 Jun 10.

    PubMed 31112338
  • [9] Wang Cuilan, Huang Yuting, Zeng Qing, et al. Study on postoperative fasting water prohibition time under ERAS concept [J]. Clinical Medical Engineering, 2022,29 (4): 2.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose and Routine feeding in people with Total Knee Arthroplasty and Postoperative Oral Carbohydrates, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 May 2023. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Pre-albumin levels at fasting (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05603364, which also lists 9 linked publications.

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 1 May 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in