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Magnesium Sulfate and Neuroendocrine Hormone

Primary Purpose

Arthropathy of Knee, Magnesium Sulfate, Cortisol

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Magnesium sulfate
Isotonic Saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arthropathy of Knee

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group M

Group S

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Postoperative pain
Numerical rating scale pain score
Postoperative pain
Numerical rating scale pain score
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Nausea
Incidence of nausea
Nausea
Incidence of nausea
Vomiting
Incidence of vomiting
Vomiting
Incidence of vomiting
Anti-emetics
Amounts of anti-emetics consumption
Anti-emetics
Amounts of anti-emetics consumption

Full Information

First Posted
August 13, 2020
Last Updated
September 22, 2021
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04514731
Brief Title
Magnesium Sulfate and Neuroendocrine Hormone
Official Title
Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Magnesium Sulfate, Cortisol, Dehydroepiandrosterone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group M
Arm Type
Experimental
Arm Description
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
Arm Title
Group S
Arm Type
Placebo Comparator
Arm Description
Patients in the saline group received the same volume of isotonic saline over the same period with magnesium infusion protocol
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Isotonic Saline
Intervention Description
Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.
Primary Outcome Measure Information:
Title
The profiles of cortisol in the saliva
Description
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
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
Title
The profiles of dehydroepiandrosterone (DHEA) in the saliva
Description
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
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
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Numerical rating scale pain score
Time Frame
Postoperative 24 hour
Title
Postoperative pain
Description
Numerical rating scale pain score
Time Frame
Postoperative 48 hour
Title
Patient controlled analgesia (PCA)
Description
Amounts of PCA consumption
Time Frame
Postoperative 24 hour
Title
Patient controlled analgesia (PCA)
Description
Amounts of PCA consumption
Time Frame
Postoperative 48 hour
Title
Nausea
Description
Incidence of nausea
Time Frame
Postoperative 24 hour
Title
Nausea
Description
Incidence of nausea
Time Frame
Postoperative 48 hour
Title
Vomiting
Description
Incidence of vomiting
Time Frame
Postoperative 24 hour
Title
Vomiting
Description
Incidence of vomiting
Time Frame
Postoperative 48 hour
Title
Anti-emetics
Description
Amounts of anti-emetics consumption
Time Frame
Postoperative 24 hour
Title
Anti-emetics
Description
Amounts of anti-emetics consumption
Time Frame
Postoperative 48 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Jung Shin, MD., PhD.
Phone
0317877508
Email
hjshin.anesth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Jung Shin, MD., PhD.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Jung Shin, Ph.D., M.D.
Phone
82317877499
Email
hjshin.anesth@gmail.com

12. IPD Sharing Statement

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Magnesium Sulfate and Neuroendocrine Hormone

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