Preoperative Hydration Drink for Joint Surgery Recovery

Overseen By Jose Rodriguez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Diabetes, Chronic kidney disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

312 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.

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 data supports the effectiveness of the treatment Preoperative Oral Hydration for joint surgery recovery?

Research suggests that using oral rehydration solutions before surgery can help manage fluids and electrolytes effectively, similar to intravenous methods. This approach may reduce dehydration and stabilize blood pressure during surgery, which can be beneficial for recovery. ^{1 2 3 4 5}

Is preoperative oral hydration safe for humans?

Research shows that preoperative oral hydration, including oral rehydration solutions like OS-1, is generally safe for surgical patients. Studies have compared it to traditional intravenous methods and found it to be a safe alternative for managing fluids and electrolytes before surgery. ^{1 4 5 6 7}

How is the preoperative oral hydration treatment different from other treatments for joint surgery recovery?

Preoperative oral hydration is unique because it uses an oral rehydration solution (a drink) instead of the more common intravenous fluids to manage fluids and electrolytes before surgery. This approach can help prevent dehydration and reduce the need for additional fluids during surgery, potentially leading to a smoother recovery. ^{1 2 4 5 8}

Research Team

Jose Rodriguez, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

This trial is for people getting same-day knee or hip arthroplasty (liner exchange only) and scheduled before noon. They must agree to leave the hospital the same day with an adult to stay overnight. Not for those underweight/overweight, forced into ambulatory surgery by insurance, pregnant, diabetic, with kidney disease/clotting/neurological issues affecting limb control, heart problems, sleep apnea, opioid dependence or poor kidney function.

Inclusion Criteria

Candidates for ambulatory revision hip arthroplasty (liner exchange only)

Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge

Candidates for ambulatory revision knee arthroplasty (liner exchange only)

Exclusion Criteria

Your body mass index (BMI) is either too low or too high.

Patients scheduled as ambulatory due to insurance mandates

You are currently pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Preparation

Participants follow preoperative fluid management guidelines, including consumption of a complex carbohydrate drink for the experimental group

1 day

1 visit (in-person)

Surgery and Immediate Recovery

Participants undergo total joint arthroplasty and immediate postoperative recovery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for safety and effectiveness, including physical therapy sessions and assessment of orthostatic hypotension

1 week

Follow-up

Participants are assessed for long-term outcomes, including HOOS JR, KOOS JR, and VR-12 scores

4 months

Treatment Details

Interventions

• Preoperative Oral Hydration

Trial Overview The study tests if drinking a complex carbohydrate drink before surgery can help patients go home sooner after ambulatory total joint arthroplasty without complications that would prevent them from leaving ('failure to launch').

Participant Groups

Group I: Complex Carbohydrate Drink Group Experimental Treatment 1 Intervention

The patients will drink a 400ml drink that contains 50g of complex carbohydrates, 3 hours prior to the surgery. The drink will be given once at the preoperative holding area. Patients are not allowed to eat solid foods after 12am the morning of surgery and can only drink clear fluids up to 3 hours prior to the surgery.

Group II: No-Complex Carbohydrate Drink Group Active Control 1 Intervention

These patients will follow normal institutional preoperative fluid management guidelines, this consist of no solid foods after 12am the morning of surgery. Patients are allowed to drink clear liquids (water, clear fruit juices, coffee) from 12am the morning of surgery up to 3 hours prior to the surgery.

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Findings from Research

In a study of 126 patients over 60 years old undergoing elective lower limb surgeries, preoperative oral rehydration solution (ORS) significantly reduced the incidence of transient electrocardiographic ischaemic changes after spinal anaesthesia compared to conventional fasting.

Patients who received ORS experienced fewer hemodynamic issues, such as hypotension and tachycardia, indicating that ORS supplementation may enhance cardiovascular stability during the postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Preoperative Oral Rehydration Solution on Myocardial Ischaemia During Orthopaedic Surgery under Spinal Anaesthesia: A Prospective Randomised Study. Mj, H., Jain, G., Gupta, P., et al.[2023]

Preoperative oral rehydration solution (ORS) significantly improves hemodynamic stability during anesthesia induction, as indicated by a higher cardiac index (CI) in patients who consumed ORS compared to those who did not.

Patients who drank ORS also experienced a significant reduction in stroke volume variation (SVV) and required less total fluid during anesthesia, suggesting that ORS helps maintain better blood volume and reduces fluid needs during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Effect of Preoperative Oral Rehydration on Hemodynamic Changes during Induction of Anesthesia and Intraoperative Fluid Management]. Tsutsui, M., Ishigaki, S., Kanaya, A., et al.[2018]

Oral rehydration therapy can be beneficial for elderly patients before surgery, particularly for those undergoing general anesthesia, as it helps address their inability to retain water effectively.

While oral rehydration is generally preferred over intravenous hydration for elderly patients, it should be used cautiously in those with swallowing difficulties, cognitive impairments, or other related health issues, requiring close monitoring by hospital staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral rehydration therapy before surgery in elderly patients]. Ogura, M.[2011]

Oral rehydration therapy (ORT) was found to be a safe and effective method for managing fluid and electrolytes in surgical patients, as demonstrated in a study involving 1,078 patients consuming an oral rehydration solution before anesthesia.

The pilot study indicated that ORT effectively supplied necessary water, electrolytes, and carbohydrates, with minimal adverse effects, such as only one instance of vomiting and no cases of aspiration reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rehydration therapy for preoperative fluid and electrolyte management. Taniguchi, H., Sasaki, T., Fujita, H.[2021]

Oral rehydration therapy (ORT) was found to be more effective than intravenous therapy in maintaining serum sodium levels and hematocrit values in surgical patients, with significant differences observed in a study of 50 female patients undergoing breast surgery.

Patients receiving ORT reported higher satisfaction levels and experienced less esophageal-pharyngeal fluid volume after anesthesia induction, suggesting that ORT is a safer and more comfortable alternative for preoperative fluid management when gastric emptying is not a concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative fluid and electrolyte management with oral rehydration therapy. Taniguchi, H., Sasaki, T., Fujita, H., et al.[2021]

A study involving 147 patients showed that using jelly-type oral rehydration solutions (OS-1 jelly) before surgery is safe, as it resulted in liquid gastric content without causing aspiration pneumonia or reflux during anesthesia induction.

The volume and pH of gastric fluid after using OS-1 jelly were comparable to those of liquid solutions, indicating that jelly-type rehydration can effectively manage preoperative hydration when water intake is properly timed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use and Safety of Preoperative Oral Rehydration Therapy Using a Jelly Type Oral Rehydration Solution]. Yamada, T., Mukai, N., Tsuchida, K., et al.[2018]

In a study involving eight healthy volunteers, OS-1, an oral rehydration solution, was found to have a gastric emptying time similar to that of water, indicating it is processed by the body in a comparable manner.

In elective surgical patients, drinking OS-1 up to two hours before anesthesia did not result in increased gastric volume, suggesting it is safe for preoperative fluid management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of preoperative oral rehydration therapy]. Mimura, F., Sakurai, Y., Uchida, M., et al.[2019]

Oral rehydration therapy (ORT) is an effective treatment for mild to moderate dehydration in children and should be used more frequently instead of intravenous (IV) therapy, which is often overused.

Using ORT aligns with guidelines from the American Academy of Pediatrics and the World Health Organization, as it allows for quicker initiation, enhances comfort, and can be administered at home, reducing the need for hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of mild to moderate dehydration in children with oral rehydration therapy. Diggins, KC.[2008]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Role of Preoperative Oral Rehydration Solution on Myocardial Ischaemia During Orthopaedic Surgery under Spinal Anaesthesia: A Prospective Randomised Study. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

[The Effect of Preoperative Oral Rehydration on Hemodynamic Changes during Induction of Anesthesia and Intraoperative Fluid Management]. [2018]

3. Japan pubmed.ncbi.nlm.nih.gov

[Oral rehydration therapy before surgery in elderly patients]. [2011]

4. Australia pubmed.ncbi.nlm.nih.gov

Oral rehydration therapy for preoperative fluid and electrolyte management. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Preoperative fluid and electrolyte management with oral rehydration therapy. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

[Use and Safety of Preoperative Oral Rehydration Therapy Using a Jelly Type Oral Rehydration Solution]. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

[Safety of preoperative oral rehydration therapy]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of mild to moderate dehydration in children with oral rehydration therapy. [2008]