Clinical trial NCT03253224: Magnesium and Postoperative Pain
Official title: The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Pain After Total Knee Arthroplasty in Patients Sedated With Dexmedetomidine Under Spinal Anesthesia: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthritis Knee
Magnesium Sulfate
Dexmedetomidine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2017-08-17
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.

To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.

Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo total knee arthroplasty under spinal anesthesia
* Patients who want to sedation during the surgery
* American Society of Anesthesiologists physical status classification 1 and 2

Exclusion Criteria:

* General anesthesia
* Patients who do not want to sedation during the surgery
* Patients who do not receive patient controlled analgesia postoperatively
* Muscular disease
* Hypermagnesemia
* Atrioventricular block

Primary outcomes:
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 24 hour
Secondary outcomes:
measure: Numerical rating scale
timeFrame: Postoperative 24 hour
measure: Rescue analgesics
timeFrame: Postoperative 24 hour
measure: Nausea
timeFrame: Postoperative 24 hour
measure: Vomiting
timeFrame: Postoperative 24 hour
measure: Antiemetics
timeFrame: Postoperative 24 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: