Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty

NCT05867264 | Unknown Early Phase 1

• 1 other identifier: Nanjing First Hospital
• Study Type: interventional
• Target: 672
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty

Conditions

Postoperative Oral Carbohydrates; Postoperative Recovery; Unilateral Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day after surgery

Secondary Outcomes (14)

• Insulin resistance index at fasting

  on the day of the surgery

• Insulin resistance index at fasting

  3 days after surgery

• Pre albumin levels and retinol binding protein levels

  on the day of surgery, 1 day and 3 days after surgery.

• The 15-item recovery quality rating scale （QoR-15）

  Up to 48 hours postoperative

• The NRS score for the thirst thirst and hunger.

  2 hours, 6 hours and 8 hours after surgery

Study Arms (3)

EOF 1 group：Early drinking water group

PLACEBO COMPARATOR

After passing the evaluation by the anesthesiologist team in PACU, the EOF1 group drank 200ml of water.

Other: Early drinking water

EOF 2 group: Early oral carbohydrate group

EXPERIMENTAL

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).

Combination Product: Early consumption of carbohydrates

Control group: Late feeding group

PLACEBO COMPARATOR

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

Other: Late feeding group

Interventions

Early drinking water OTHER

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 1 group：Early drinking water group

Early consumption of carbohydrates COMBINATION_PRODUCT

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.

EOF 2 group: Early oral carbohydrate group

Late feeding group OTHER

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

Control group: Late feeding group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-79 years.
• Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
• Normal diet.
• ASA grade I\~Ⅲ;
• BMI 18-30kg /m2.
• No intraspinal anesthesia contraindications.

You may not qualify if:

• Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
• 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.

Sponsors & Collaborators

• Hongwei Shi: lead

Related Publications (9)

• 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.

  PMID: 25391735 BACKGROUND

• 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.

  PMID: 31309323 BACKGROUND

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

  PMID: 25827282 BACKGROUND

• 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

• 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.

  PMID: 27840308 BACKGROUND

• 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

• 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.

  PMID: 25121931 BACKGROUND

• 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.

  PMID: 31112338 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.

  BACKGROUND

Central Study Contacts

Liu Han

CONTACT

18951670163; han_cold.student@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Anesthesiology

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 19, 2023
• Study Start: May 25, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share