Arthropathy of KneePhase 4NCT04514731
Magnesium Sulfate and Neuroendocrine Hormone
A Phase 4 study testing Magnesium sulfate and Isotonic Saline in people with Arthropathy of Knee and Magnesium Sulfate, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Arthropathy of Knee, Magnesium Sulfate, Cortisol
- What is being tested?
- Magnesium sulfate and Isotonic Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2021to 15 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo staged bilateral total knee arthroplasty
- Spinal anesthesia
- American Society of Anesthesiologists physical status 1 and 2
Who cannot join
- Patients who undergo unilateral total knee arthroplasty
- General anesthesia
- Musculoskeletal disease
- Hypermagnesemia
- Atrioventricular block
- Previous history of administration of calcium channel blockers
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Hyun-Jung Shin, Ph.D., M.D., 82317877499, hjshin.anesth@gmail.com
About this study
Official title: Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
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.
Read more
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.
- Being tested
- Magnesium sulfate, Isotonic Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
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.
Isotonic SalineDrug
Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Numerical rating scale pain score
Measured: Postoperative 24 hour
Postoperative pain
Numerical rating scale pain score
Measured: Postoperative 48 hour
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Measured: Postoperative 24 hour
Patient controlled analgesia (PCA)
Amounts of PCA consumption
Measured: Postoperative 48 hour
Nausea
Incidence of nausea
Measured: Postoperative 24 hour
Nausea
Incidence of nausea
Measured: Postoperative 48 hour
Vomiting
Incidence of vomiting
Measured: Postoperative 24 hour
Vomiting
Incidence of vomiting
Measured: Postoperative 48 hour
Anti-emetics
Amounts of anti-emetics consumption
Measured: Postoperative 24 hour
Anti-emetics
Amounts of anti-emetics consumption
Measured: Postoperative 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start21 Jan 2021
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Hyun-Jung Shin, Seoul National University Hospital
- Investigators
- Hyun-Jung Shin, MD., PhD., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514731
- Sponsor's protocol ID
- B-2008/631-002
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
- ClinicalTrials.gov ID
- NCT04514731
- Acronym / sponsor ID
- B-2008/631-002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Experimental | Drug: Magnesium sulfatePatients 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 |
| Group S | Placebo comparator | Drug: Isotonic SalinePatients in the saline group received the same volume of isotonic saline over the same period with magnesium infusion protocol |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo staged bilateral total knee arthroplasty
- Spinal anesthesia
- American Society of Anesthesiologists physical status 1 and 2
Key exclusion criteria (6 listed)
- Patients who undergo unilateral total knee arthroplasty
- General anesthesia
- Musculoskeletal disease
- Hypermagnesemia
- Atrioventricular block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateMagnesium 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 | Group M |
| Isotonic SalineIsotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group. | Drug | Group S |
Primary outcome
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
10 secondary outcomes
Postoperative pain
Time frame: Postoperative 24 hour
Postoperative pain
Time frame: Postoperative 48 hour
Patient controlled analgesia (PCA)
Time frame: Postoperative 24 hour
Patient controlled analgesia (PCA)
Time frame: Postoperative 48 hour
Nausea
Time frame: Postoperative 24 hour
Nausea
Time frame: Postoperative 48 hour
Vomiting
Time frame: Postoperative 24 hour
Vomiting
Time frame: Postoperative 48 hour
Anti-emetics
Time frame: Postoperative 24 hour
Anti-emetics
Time frame: Postoperative 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Jung Shin, MD., PhD. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate and Isotonic Saline in people with Arthropathy of Knee and Magnesium Sulfate, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jung Shin, MD., PhD. (0317877508, hjshin.anesth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.