Magnesium Sulfate and Neuroendocrine Hormone

NCT04514731 | Unknown Phase 4

• 1 other identifier: B-2008/631-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee; Magnesium Sulfate; Cortisol; Dehydroepiandrosterone

Outcome Measures

Primary Outcomes (2)

• The profiles of cortisol in the saliva

  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

  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 profiles of dehydroepiandrosterone (DHEA) in the saliva

  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

  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

Secondary Outcomes (10)

• Postoperative pain

  Postoperative 24 hour

• Postoperative pain

  Postoperative 48 hour

• Patient controlled analgesia (PCA)

  Postoperative 24 hour

• Patient controlled analgesia (PCA)

  Postoperative 48 hour

• Nausea

  Postoperative 24 hour

Study Arms (2)

Group M

EXPERIMENTAL

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

Group S

PLACEBO COMPARATOR

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

Drug: Isotonic Saline

Interventions

Magnesium sulfate DRUG

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.

Group M

Isotonic Saline DRUG

Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.

Group S

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

MeSH Terms

Interventions

Magnesium Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Hyun-Jung Shin, MD., PhD.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Jung Shin, MD., PhD.

CONTACT

0317877508; hjshin.anesth@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: January 21, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

KR (1)