NCT04514731

Magnesium Sulfate and Neuroendocrine Hormone

Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthropathy of Knee
• Magnesium Sulfate
• Cortisol
• Dehydroepiandrosterone

Interventions

Type	Name	Description
DRUG	Magnesium sulfate	Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of isotonic saline over 15 minutes after spinal anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/hour) until the end of surgery.
DRUG	Isotonic Saline	Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2020-08-17
• Last updated: 2021-09-24

Locations

1 site across 1 country: South Korea