Arthritis Knee, Dexmedetomidine, Magnesium Sulfate
Conditions
Brief summary
With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period. To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries. Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.
Interventions
DRUGMagnesium Sulfate
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
DRUGNormal saline
Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
Sponsors
Seoul National University Bundang Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who undergo total knee arthroplasty under spinal anesthesia * Patients who want to sedation during the surgery * American Society of Anesthesiologists physical status classification 1 and 2
Exclusion criteria
* General anesthesia * Patients who do not want to sedation during the surgery * Patients who do not receive patient controlled analgesia postoperatively * Muscular disease * Hypermagnesemia * Atrioventricular block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient controlled analgesia (PCA) | Postoperative 24 hour | Amounts of PCA consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale | Postoperative 24 hour | Postoperative pain score |
| Rescue analgesics | Postoperative 24 hour | Amounts of the analgesics administered to mange the postoperative pain |
| Nausea | Postoperative 24 hour | Incidence of nausea |
| Vomiting | Postoperative 24 hour | Incidence of vomiting |
| Antiemetics | Postoperative 24 hour | Amounts of antiemetics consumption |
Countries
South Korea
Outcome results
None listed