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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03253224
Other study ID # B-1707/406-006
Secondary ID
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
Health authority
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

Study Design


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
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