Magnesium Sulfate and Neuroendocrine Hormone

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Dehydroepiandrosterone; Magnesium Sulfate; Cortisol; Arthropathy of Knee

Treatments: Drug: Magnesium sulfate; Drug: Isotonic Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04514731

B-2008/631-002

Details and patient eligibility

About

Total knee arthroplasty is a procedure that relieves pain in patients with severe symptomatic osteoarthritis, but it can be associated with postoperative pain, which hinders recovery. In the previous study, we reported evidence of increased pain in patients undergoing staged total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) as a result of the surgical injury to the first operated knee.

Magnesium sulfate is an effective analgesic adjuvant for postoperative pain. Its analgesic property seems to be associated with the regulation of calcium influx into the cells, or antagonism of N-methyl-D-aspartate receptors in the central nervous system. Additionally, magnesium is known to have an anti-inflammatory effect. Inflammatory state may accompany with pain via peripheral or central sensitization.

Recently, we reported that magnesium sulfate effectively attenuates not only postoperative pain but also increased pain intensity without serious adverse effects in the bilateral staged total knee arthroplasty. However, the exact mechanism regarding these effects of magnesium sulfate remains unclear.

In the present study, we will investigate the analgesic mechanism of magnesium sulfate via analysis of endocrine neurosteroid levels in patients undergoing bilateral staged total knee arthroplasty.

Enrollment: 30 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who undergo staged bilateral total knee arthroplasty
• Spinal anesthesia
• American Society of Anesthesiologists physical status 1 and 2

Exclusion criteria

• Patients who undergo unilateral total knee arthroplasty
• General anesthesia
• Musculoskeletal disease
• Hypermagnesemia
• Atrioventricular block
• Previous history of administration of calcium channel blockers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups, including a placebo group

Group M

Experimental group

Description:

Patients in the magnesium sulfate group received magnesium sulfate 50 mg/kg for 15 minutes after spinal anesthesia and then 15 mg/kg/hour by continuous intravenous infusion until the end of surgery

Treatment:

Drug: Magnesium sulfate

Group S

Placebo Comparator group

Description:

Patients in the saline group received the same volume of isotonic saline over the same period with magnesium infusion protocol

Treatment:

Drug: Isotonic Saline