Magnesium Sulfate and Neuroendocrine Hormone

Arthropathy of Knee Clinical Trial

Official title:

Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04514731
• Other study ID #: B-2008/631-002
• Status: Recruiting
• Phase: Phase 4
• Start date: January 21, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: Hyun-Jung Shin, MD., PhD.
• Phone: 0317877508
• Email: hjshin.anesth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Cortisol
• Dehydroepiandrosterone
• Joint Diseases
• Magnesium Sulfate

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Postoperative pain	Numerical rating scale pain score	Postoperative 24 hour
Secondary	Postoperative pain	Numerical rating scale pain score	Postoperative 48 hour
Secondary	Patient controlled analgesia (PCA)	Amounts of PCA consumption	Postoperative 24 hour
Secondary	Patient controlled analgesia (PCA)	Amounts of PCA consumption	Postoperative 48 hour
Secondary	Nausea	Incidence of nausea	Postoperative 24 hour
Secondary	Nausea	Incidence of nausea	Postoperative 48 hour
Secondary	Vomiting	Incidence of vomiting	Postoperative 24 hour
Secondary	Vomiting	Incidence of vomiting	Postoperative 48 hour
Secondary	Anti-emetics	Amounts of anti-emetics consumption	Postoperative 24 hour
Secondary	Anti-emetics	Amounts of anti-emetics consumption	Postoperative 48 hour