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Clinical Trials/NCT04514731
NCT04514731
Unknown
Phase 4

Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients

Seoul National University Hospital1 site in 1 country30 target enrollmentJanuary 21, 2021

Overview

Phase
Phase 4
Intervention
Magnesium sulfate
Conditions
Arthropathy of Knee
Sponsor
Seoul National University Hospital
Enrollment
30
Locations
1
Primary Endpoint
The profiles of cortisol in the saliva
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
December 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyun-Jung Shin

Associate Professor

Seoul National University Hospital

Eligibility Criteria

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

Arms & Interventions

Group M

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

Intervention: Magnesium sulfate

Group S

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

Intervention: Isotonic Saline

Outcomes

Primary Outcomes

The profiles of cortisol in the saliva

Time Frame: From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation

The cortisol concentrations in the saliva, at the evening before the operation (21:00\~22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up

The profiles of dehydroepiandrosterone (DHEA) in the saliva

Time Frame: From the evening (21:00) before the operation day to the morning (60 minutes after wake-up) of the operation day, for each stage of the operation

The DHEA concentrations in the saliva, at the evening before the operation (21:00\~22:00), just after wake-up in the morning of the operation day, and 30 and 60 minutes after wake-up

Secondary Outcomes

  • Anti-emetics(Postoperative 48 hour)
  • Vomiting(Postoperative 48 hour)
  • Postoperative pain(Postoperative 48 hour)
  • Patient controlled analgesia (PCA)(Postoperative 48 hour)
  • Nausea(Postoperative 48 hour)

Study Sites (1)

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