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NCT04514731
Magnesium Sulfate and Neuroendocrine Hormone
Phase 4 trial testing Magnesium sulfate in Arthropathy of Knee in 30 participants. Status unknown.
15 December 2021
Quick facts
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 21 January 2021 |
| Primary completion | 15 December 2021 |
| Estimated completion | 15 December 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Magnesium sulfate — full drug profile →
- Isotonic Saline — full drug profile →
Conditions studied
- Arthropathy of Knee — all drugs for Arthropathy of Knee →
- Magnesium Sulfate — all drugs for Magnesium Sulfate →
- Cortisol — all drugs for Cortisol →
- Dehydroepiandrosterone — all drugs for Dehydroepiandrosterone →
Sponsor
Seoul National University Hospital
Who can join
Adults 30 to 80, female only, with Arthropathy of Knee or Magnesium Sulfate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04514731
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Related trials
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Trials testing the same drug.
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- NCT07213037 — Magnesium Sulfate Versus Lidocaine as Additives to Dexmedetomidine for Cough Suppression After Functional Endoscopic Sin · Phase 3 · not yet recruiting
- NCT06979141 — Dexmedetomidine, Magnesium Sulphate and Lidocaine for Cough Suppression After General Anesthesia · Phase 3 · recruiting
- NCT07131033 — Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholec · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Arthropathy of Knee
Currently open trials in the same condition.
- NCT07180953 — Impact of Dexamethasone Route on Pain and Inflammation in iPACK With ACB for Knee Arthroplasty · Phase 4 · recruiting
- NCT05290818 — Total Versus Robotic Assisted Unicompartmental Knee Replacement · NA · recruiting
- NCT06832995 — Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties · active not recruiting
- NCT03869996 — Total Knee Arthroplasty: Fast Track Protocol is the Future? · NA · recruiting
- NCT03674697 — The Effect of Light Therapy on Post-Surgical Pain · NA · active not recruiting
Other Seoul National University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04514731 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
- Last refreshed: 24 September 2021
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