MedTrace Logo

Magnesium Sulfate and Neuroendocrine Hormone

NCT04514731 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyun-Jung Shin, MD., PhD. · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2021-12-15
Completion
2021-12-15

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514731 on ClinicalTrials.gov