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.
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
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Oral Carbohydrates, Postoperative Recovery
- 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.
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.
- 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
- 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.
- 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.
- Conditions
- Total Knee Arthroplasty, Postoperative Oral Carbohydrates, Postoperative Recovery, Elderly Patients
- 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 group | Role | What they receive |
|---|---|---|
| EOF group:early carbohydrate feeding | Experimental | 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. Receives: Combination Product: 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose |
| Control group:conventional feeding | Experimental | Patients 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.
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)
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
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
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)
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)
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
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
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
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
length of patient stays
The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous
Measured: Up to 7days postoperative
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
The incidence of reflux aspiration
The reduced incidence of reflux aspiration indicates that early postoperative carbohydrate administration is advantageous
Measured: 24 hours after surgery
The incidence rate of hypoxemia
The reduced incidence of hypoxemia suggests that early postoperative carbohydrate administration is advantageous
Measured: 24 hours after surgery
Patient satisfaction score
Rated on a 0-10 scale, with a higher score representing greater satisfaction.
Measured: Up to 48 hours postoperative
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
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
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.
- First posted2 Nov 2022
- Study start22 Nov 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 25391735Rizvanovic 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 31309323Nygren 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 25121931Noba 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Oral Carbohydrate Administration in Total Knee Arthroplasty Elderly Patients
- ClinicalTrials.gov ID
- NCT05603364
- Acronym / sponsor ID
- Nanjing First Hospital Han Liu
- Conditions
- Total Knee Arthroplasty, Postoperative Oral Carbohydrates, Postoperative Recovery, Elderly Patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 Nov 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.
To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients.
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.
- 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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOF group:early carbohydrate feeding | Experimental | Combination Product: 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucoseThe 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. |
| Control group:conventional feeding | Experimental | Other: Routine feedingPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucoseDrank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room. | Combination product | EOF group:early carbohydrate feeding |
| Routine feedingPatients 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 | Other | Control group:conventional feeding |
Primary outcome
Pre-albumin levels at fasting
Time frame: 1 day after surgery
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
16 secondary outcomes
Pre-albumin levels at fasting
Time frame: On the day of the surgery
Pre-albumin levels at fasting
Time frame: 3 days after surgery
Retinol-binding protein levels at fasting levels
Time frame: Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)
Insulin resistance index at fasting
Time frame: Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)
The NRS score for the thirst condition
Time frame: 2 hours, 6 hours and 8 hours after surgery
The NRS score for the starvation conditions
Time frame: 2 hours, 6 hours and 8 hours after surgery
The degree of abdominal distension
Time frame: 24 hours after surgery
Time of the first anal exhaust after surgery
Time frame: Up to 48 hours postoperative
length of patient stays
Time frame: Up to 7days postoperative
Time of first ambulation after surgery
Time frame: Up to 48 hours postoperative
The incidence of reflux aspiration
Time frame: 24 hours after surgery
The incidence rate of hypoxemia
Time frame: 24 hours after surgery
Patient satisfaction score
Time frame: Up to 48 hours postoperative
The incidence and severity of various adverse events (AE) from the start of oral carbohydrates until the end of the trial
Time frame: Up to 48 hours postoperative
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;
Time frame: Up to 48 hours postoperative
Number of antiemetic drugs used within 24h of initial administration until the first start of administration
Time frame: Up to 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background: PubMed 25391735Miller 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.
- Background: PubMed 31309323Rizvanovic 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.
- Background: PubMed 25827282Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.
- Background[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.
- Background: PubMed 27840308Yang 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.
- Background[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.
- Background: PubMed 25121931Smith 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.
- Background: PubMed 31112338Noba 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.
- Background[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.
- Individual participant dataSharing planned: No
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Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.