Carbohydrate Loading for Spine Surgery Preparation

Overseen By Kevan Kostynski

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Horizon Health Network

Disqualifiers: Diabetes, Revision surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether consuming a carbohydrate-rich sports drink, such as Gatorade Thirst Quencher, before spine surgery can help older patients recover faster and avoid complications. It targets individuals aged 65 and older undergoing specific spine surgeries, such as fusion or decompression. Participants will either adhere to the usual pre-surgery diet or include the sports drink in their routine. Suitable candidates have scheduled elective spine surgery and are not diabetic. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance recovery outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that carbohydrate loading is safe for elderly patients undergoing spine surgery?

Research has shown that drinking a carbohydrate drink like Gatorade Thirst Quencher before surgery is generally safe for most people. One study found that consuming this drink a few hours before surgery did not lead to major safety issues. However, another study reported some rare cases of infections after surgery. Overall, Gatorade and similar drinks are usually well-tolerated when used pre-surgery. For those considering joining the trial, it is reassuring to know that this method has been safely used in other surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about carbohydrate loading with Gatorade Thirst Quencher for spine surgery preparation because it's a simple, non-invasive method that could enhance preoperative readiness. Unlike the standard fasting guidelines, which may leave patients feeling weak and dehydrated, this approach allows them to consume a carbohydrate-rich drink up to two hours before surgery. The idea is that these carbohydrates can help maintain energy levels and potentially improve recovery times, offering a practical and easily accessible option for patients facing elective spine surgery.

What evidence suggests that carbohydrate loading is effective for reducing hospital stay and adverse events in elderly spine surgery patients?

This trial will compare the effects of carbohydrate loading with a control group for spine surgery preparation. Research has shown that drinking carbohydrate-rich drinks, such as Gatorade, before surgery can be beneficial. Participants in the carbohydrate group will consume a carbohydrate sports drink before their procedure. Studies have found that patients who consume these drinks often leave the hospital sooner. The drinks help maintain energy levels and reduce the stress of fasting before surgery. Additionally, these drinks can lower anxiety and thirst before the procedure. These benefits make carbohydrate drinks a promising option for improving outcomes in older patients undergoing spine surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Chris Small, MD

Principal Investigator

Canada East Spine Centre

Are You a Good Fit for This Trial?

This trial is for elderly patients aged 65 or older who are scheduled for, or have recently had, elective spine surgery (fusion, decompression, discectomy). It's not open to those under 65, those with diabetes, anyone unable to drink the carbohydrate solution provided (Gatorade), or if they don't agree to join the study.

Inclusion Criteria

I meet the age requirement for the trial.

I am scheduled for or have recently had spine surgery.

Exclusion Criteria

Are not able to consume the selected carbohydrate drink

I meet the age requirements for the trial.

I have had or will have surgery on my neck or lower back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Nutrition

Participants consume a carbohydrate drink up to 2 hours prior to surgery

1 day

1 visit (in-person)

Surgery and Hospital Stay

Participants undergo elective spine surgery and are monitored for length of stay and adverse events

0-Maximum hours required

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gatorade Thirst Quencher

Trial Overview The study tests whether drinking Gatorade before spine surgery can help elderly patients by shortening their hospital stay and reducing complications. Patients will be compared based on whether they received this preoperative carbohydrate loading versus those who did not.

How Is the Trial Designed?

Group I: Carbohydrate Group Experimental Treatment 1 Intervention

Standard of care for dietary instructions + carbohydrate loading. The carbohydrate (CHO) group will consist of prospectively recruited patients scheduled to undergo an elective spine surgery. These participants will also follow the preoperative nutrition standards, however, in addition, they will be instructed to consume 710ml of a simple, commercial carbohydrate sports drink on the day of their procedure up to 2 hours prior to surgery.

Group II: Control Group Active Control 1 Intervention

Standard of care for dietary instructions only. The control group will consist of retrospectively recruited participants who have recently undergone a successful elective spine surgery, and followed the preoperative nutrition standards for their surgery, as outlined by the research institution's fasting dietary guidelines. Recruitment will include the most recent spine surgeries that meet the inclusion criteria and match prospective patient demographics.

Who Is Running the Clinical Trial?

Horizon Health Network

Lead Sponsor

Trials

30

Recruited

16,800+

Citations

1. withpower.com withpower.com/trial/phase-diet-carbohydrate-loading-6-2022-d1c3d

Carbohydrate Loading for Spine Surgery Preparation The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8161920/

A U.S. survey of pre-operative carbohydrate-containing ... Carbohydrate-containing drinks (CCD) are administered preoperatively in most enhanced recovery after surgery (ERAS) programs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7477936/

Effects of a Preoperative Carbohydrate-Rich Drink Before ... 200 mL of oral carbohydrate beverage 2 hr before ambulatory surgery is safe, effective, and can be used for preoperative management of fasting patients.

4. researchgate.net researchgate.net/publication/51513709_Pre-operative_nutrition_and_carbohydrate_loading

Pre-operative nutrition and carbohydrate loading 29,30 Specifically, protein loss has been shown to be significant at 2 weeks postoperatively and may not return to baseline levels by 6 months ...

5. qualityhealth.org qualityhealth.org/scoap/wp-content/uploads/sites/2/2021/06/SCOAP-Preoperative-Carbohydrate-Loading-FINAL.pdf

Pre-Operative Carbohydrate Loading Patients receiving preoperative carbohydrate loading have been found to have a lesser degree or anxiety and thirst immediately prior to surgery. Pogatschnik, C.

6. researchgate.net researchgate.net/publication/365672730_Effects_of_preoperative_carbohydrate_loading_on_recovery_after_elective_surgery_A_systematic_review_and_Bayesian_network_meta-analysis_of_randomized_controlled_trials

Effects of preoperative carbohydrate loading on recovery ... In terms of safety, oral low-dose carbohydrate administration was associated with the occurrences of postoperative infection compared with ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05778487/carbohydrate-loading-and-elderly-patients-undergoing-spine-surgery

Carbohydrate Loading and Elderly Patients Undergoing ... The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing ...