Magnesium and Postoperative Pain

Dexmedetomidine Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03253224
• Other study ID #: B-1707/406-006
• Status: Terminated
• Phase: Phase 4
• First received: August 15, 2017
• Last updated: April 16, 2018
• Start date: September 10, 2017
• Est. completion date: March 29, 2018

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis Knee
• Dexmedetomidine
• Magnesium Sulfate
• Pain, Postoperative

Intervention

Drug:
• Magnesium Sulfate
Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
• Normal saline
Normal saline group receives the same volume of normal saline, administered according to the same method 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	Patient controlled analgesia (PCA)	Amounts of PCA consumption	Postoperative 24 hour
Secondary	Numerical rating scale	Postoperative pain score	Postoperative 24 hour
Secondary	Rescue analgesics	Amounts of the analgesics administered to mange the postoperative pain	Postoperative 24 hour
Secondary	Nausea	Incidence of nausea	Postoperative 24 hour
Secondary	Vomiting	Incidence of vomiting	Postoperative 24 hour
Secondary	Antiemetics	Amounts of antiemetics consumption	Postoperative 24 hour