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Magnesium Sulfate and Neuroendocrine Hormone

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ClinicalTrials.gov Identifier: NCT04514731
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Hyun-Jung Shin, Seoul National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Arthropathy of Knee Magnesium Sulfate Cortisol Dehydroepiandrosterone Drug: Magnesium sulfate Drug: Isotonic Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 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.
Placebo Comparator: Group S
Patients in the saline group received the same volume of isotonic saline over the same period with magnesium infusion protocol
 Drug: Isotonic Saline
Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Postoperative pain [ Time Frame: Postoperative 24 hour ]
    Numerical rating scale pain score

  2. Postoperative pain [ Time Frame: Postoperative 48 hour ]
    Numerical rating scale pain score

  3. Patient controlled analgesia (PCA) [ Time Frame: Postoperative 24 hour ]
    Amounts of PCA consumption

  4. Patient controlled analgesia (PCA) [ Time Frame: Postoperative 48 hour ]
    Amounts of PCA consumption

  5. Nausea [ Time Frame: Postoperative 24 hour ]
    Incidence of nausea

  6. Nausea [ Time Frame: Postoperative 48 hour ]
    Incidence of nausea

  7. Vomiting [ Time Frame: Postoperative 24 hour ]
    Incidence of vomiting

  8. Vomiting [ Time Frame: Postoperative 48 hour ]
    Incidence of vomiting

  9. Anti-emetics [ Time Frame: Postoperative 24 hour ]
    Amounts of anti-emetics consumption

  10. Anti-emetics [ Time Frame: Postoperative 48 hour ]
    Amounts of anti-emetics consumption


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514731


Contacts
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Contact: Hyun-Jung Shin, MD., PhD. 0317877508 hjshin.anesth@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact: Hyun-Jung Shin, Ph.D., M.D.    82317877499    hjshin.anesth@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Hyun-Jung Shin, MD., PhD. Seoul National University Bundang Hospital
More Information
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Responsible Party: Hyun-Jung Shin, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04514731    
Other Study ID Numbers: B-2008/631-002
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
 Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents