Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery

Not Applicable

Recruiting

• Conditions: Diet, Carbohydrate Loading
• Interventions: Dietary Supplement: Gatorade Thirst Quencher

• Registration Number: NCT05778487
• Lead Sponsor: Horizon Health Network

Brief Summary

Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Detailed Description

Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Because of this, preoperative carbohydrate loading has been included in the Enhanced Recovery After Surgery (ERAS) and Enhanced Recovery Canada (ERC) guidelines across a variety of surgical specialities; however, a gap in the literature remains within the field of orthopaedic surgery, specifically in cervical and thoracolumbar spine surgeries. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. This is an ambispective research study including elderly patients from the Canadian Spine Outcomes and Research Network (CSORN) registry, who have either recently undergone, or are scheduled to undergo, an orthopaedic cervical or thoracolumbar spine surgery (fusion, decompression, or discectomy). The control group will include retrospectively recruited patients, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink up to 2 hours prior to surgery. Groups will also be matched based on various patient demographic and surgical variables. LOS in hospital and perioperative patient adverse events are the outcome measurements of interest. Patient and surgical variables will also be collected for comparison. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Study Timeline

• Study First Submitted: 2022-06-22
• Study Start: 2022-07-13
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2024-07
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Patients must meet the age requirement,
• Have either recently undergone, or are scheduled to undergo an elective cervical or thoracolumbar spine surgery, including fusion, decompression, and discectomy procedures.

Exclusion Criteria

• Potential participants will be excluded if they do not meet the age requirements,
• Have had, or will be having, cervical or thoracolumbar fusion, decompression or discectomy revision surgery,
• Are not able to consume the selected carbohydrate drink,
• Do not consent to participation in the research study,
• Or have diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate Group	Gatorade Thirst Quencher	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.

Primary Outcome Measures

Name	Time	Method
Length of Stay (LOS) in Hospital	From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.	How long (hours) are the patients staying in hospital for?

Secondary Outcome Measures

Name	Time	Method
Perioperative Patient Adverse Events	From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.	Do the patients experience any adverse events in hospital such as pain, nausea, vomiting?

Trial Locations

Locations (1)

Canada East Spine Centre at Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada