Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty
NCT ID: NCT05867264
Last Updated: 2023-05-19
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
672 participants
INTERVENTIONAL
2023-05-25
2024-12-30
Brief Summary
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Detailed Description
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This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EOF 1 group：Early drinking water group
After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.
Early drinking water
After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.
The evaluation criteria for the anesthesiologist team are:
1. Steward's awakening score is ≥ 6 points.
2. Level of sobriety ≥ 3.
3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
EOF 2 group: Early oral carbohydrate group
After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose).
Early consumption of carbohydrates
After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose).
The evaluation criteria for the anesthesiologist team are:
1. Steward's awakening score is 6 points.
2. Level of sobriety ≥ 3.
3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
Control group: Late feeding group
After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat
Late feeding group
After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat
Interventions
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Early drinking water
After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.
The evaluation criteria for the anesthesiologist team are:
1. Steward's awakening score is ≥ 6 points.
2. Level of sobriety ≥ 3.
3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
Early consumption of carbohydrates
After passing the evaluation by the anesthesiologist team in PACU, the EOF2 group had a drinking capacity of 200ml of 12.5% carbohydrates (100ml containing 12.5g of maltodextrin, fructose, and glucose).
The evaluation criteria for the anesthesiologist team are:
1. Steward's awakening score is 6 points.
2. Level of sobriety ≥ 3.
3. There is no need to wait for intestinal peristalsis, based on the patient's wishes, and the feeding should be completed within 2 hours after the surgery.
Late feeding group
After observing the vital signs for 30 minutes after surgery, patients in Group C were sent back to the ward to continue fasting and drinking for at least 6 hours. After the anus exhausts, they began to gradually drink and eat
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
* Normal diet.
* ASA grade I\~Ⅲ;
* BMI 18-30kg /m2.
* No intraspinal anesthesia contraindications.
Exclusion Criteria
* Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
* History of motion sickness.
* Mental disorder, alcoholism, or a history of substance abuse.
* Patients with abnormal swallowing function.
* The operation time is greater than 3 hours.
* Maltodextrin fructose allergy or intolerance.
18 Years
79 Years
ALL
Yes
Sponsors
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Hongwei Shi
OTHER
Responsible Party
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Hongwei Shi
Director, Department of Anesthesiology
Central Contacts
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References
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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.
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.
Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.
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.
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.
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.
[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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Nanjing First Hospital
Identifier Type: -
Identifier Source: org_study_id
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