Clinical trial NCT04514731: Magnesium Sulfate and Neuroendocrine Hormone
Official title: Neuroendocrine Changes Associated With Magnesium Sulfate Administration in Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthropathy of Knee
Magnesium Sulfate
Cortisol
Dehydroepiandrosterone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-08-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: The profiles of cortisol in the saliva
timeFrame: 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
measure: The profiles of dehydroepiandrosterone (DHEA) in the saliva
timeFrame: 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:
measure: Postoperative pain
timeFrame: Postoperative 24 hour
measure: Postoperative pain
timeFrame: Postoperative 48 hour
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 24 hour
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 48 hour
measure: Nausea
timeFrame: Postoperative 24 hour
measure: Nausea
timeFrame: Postoperative 48 hour
measure: Vomiting
timeFrame: Postoperative 24 hour
measure: Vomiting
timeFrame: Postoperative 48 hour
measure: Anti-emetics
timeFrame: Postoperative 24 hour
measure: Anti-emetics
timeFrame: Postoperative 48 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun-Jung Shin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: