No registrations found.
ID
Source
Brief title
Health condition
Knee osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Orthostatic intolerance and -hypotension during first postoperative mobilization.
Secondary outcome
- Complication rate of reduced fasting (aspiration);
- Presence of postoperative nausea and vomiting;
- Length of hospital stay
Background summary
During the last decades, fast-track protocols have been implemented to improve the postoperative outcome and to reduce the lenght of hospital stay after Total Knee Arthroplasty (TKA). One of the interventions of fast-track protocols is early mobilization. This can be compromised by orthostatic intolerance and -hypotension due to various causes including prolonged fasting. Moreover, preoperative fasting is stressful for patients.
Reduced preoperative fasting was not associated with increased intake related complications. To further optimize fast-track rehabilitation it is assumed to reduce the preoperative fasting period to prevent issues during early mobilisation.
Study objective
We presume that reducing the fasting period by adding a carbohydrate drink 2-3 hours prior to surgery is a good and feasible option to decrease orthostatic intolerance and -hypotension. Moreover, the pre- and postoperative well-being is thought to be improved and thereby the overall TKA rehabilitation.
Study design
Verwachte start inclusie november 2019
Verwachte volledige inclusie december 2021
Intervention
The intervention group will receive a carbohydrate drink 2-3 hours prior to surgery
Inclusion criteria
All patients, 18 years or older, with primary or secondary osteoarthritis of the knee who qualify for a unilateral primary total knee arthroplasty.
Exclusion criteria
- Patients with risk factors for reduced fasting (metabolic disorders (Diabetes Mellitus), age >80 years);
- Insufficient command of Dutch;
- ASA >3;
- Patient who are incompetent to decide.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7996 |
| Other | METC-LDD : Z19.025 |