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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603364
• Other study ID #: Nanjing First Hospital Han Liu
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: November 22, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective knee replacement surgery.

• The patient gave informed consent.

• Age =65 years, Sex is not limited

• American Society of Anesthesiologists (ASA)?~? level

• Body Mass Index (BMI)18~28kg/m2

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Elderly Patients
• Postoperative Recovery
• Total Knee Arthroplasty

Intervention

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

Other:
• Routine feeding
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

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

[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.

[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.

[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.

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. — View Citation

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. — View Citation

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

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. — View Citation

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;(8):CD009161. doi: 10.1002/14651858.CD009161.pub2. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day after surgery
Secondary	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	On the day of the surgery
Secondary	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	3 days after surgery
Secondary	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	Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)
Secondary	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	Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3)
Secondary	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.	2 hours, 6 hours and 8 hours after surgery
Secondary	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.	2 hours, 6 hours and 8 hours after surgery
Secondary	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.	24 hours after surgery
Secondary	Time of the first anal exhaust after surgery	The advanced time of the first postoperative anal exhaust indicates a favorable early postoperative carbohydrate administration	Up to 48 hours postoperative
Secondary	length of patient stays	The shortened length of hospital stay indicated that early postoperative carbohydrate administration was advantageous	Up to 7days postoperative
Secondary	Time of first ambulation after surgery	The early time of the first postoperative ambulation indicates that early postoperative carbohydrate administration is advantageous	Up to 48 hours postoperative
Secondary	The incidence of reflux aspiration	The reduced incidence of reflux aspiration indicates that early postoperative carbohydrate administration is advantageous	24 hours after surgery
Secondary	The incidence rate of hypoxemia	The reduced incidence of hypoxemia suggests that early postoperative carbohydrate administration is advantageous	24 hours after surgery
Secondary	Patient satisfaction score	Rated on a 0-10 scale, with a higher score representing greater satisfaction.	Up to 48 hours postoperative
Secondary	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	Up to 48 hours postoperative
Secondary	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	Up to 48 hours postoperative
Secondary	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	Up to 24 hours postoperative