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The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Experimental | Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| base blood concentration of syndecan-1, heparan sulfate | preoperative baseline serum levels of syndecan-1 and heparan sulfate | within 1 hour before surgery(base concentration) |
| blood concentration of syndecan-1, heparan sulfate at the end of the surgery | blood concentration of syndecan-1, heparan sulfate at the end of the surgery | within 5 minutes after the end of surgery (when thd surgical drape is removed) |
| blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery | blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery | 2 hours after the end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D005973 | Glutamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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A Randomized, Double-Blinded, Placebo-Controlled Trial
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triple blinded (Participant, Care Provider, investigator)
|
|
| 0.9% NaCl (normal saline) | Drug | The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group). |
|
| D024361 |
| Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D021542 | Amino Acids, Neutral |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |