An interventional study of Gatorade Thirst Quencher in Diet, Carbohydrate Loading, sponsored by Horizon Health Network. Status unknown at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Horizon Health Network · Not applicable, Interventional, and Supportive care
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.
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.
Horizon Health Network is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
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.
Dietary Supplement: Gatorade Thirst Quencher
Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)
Length of Stay (LOS) in Hospital
How long (hours) are the patients staying in hospital for?
Time frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Perioperative Patient Adverse Events
Do the patients experience any adverse events in hospital such as pain, nausea, vomiting?
Time frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Plan to share: No — Data cannot be shared publicly because of legal and ethic restrictions. Data from this study are available (contact cescresearch@gmail.com) for researchers who meet the criteria for access to confidential data.
Started Jul 2022 (actual). Primary completion is estimated for Jul 2024, 24 months after the start.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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