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The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.
The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS > 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the first group: a fixed combination of Orphenadrine and Diclofenac | Experimental | dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume |
|
| the second group: patient-controlled analgesia (РСА) with Morphine | Experimental | dynamics of points 100 mm visual-analog scale,minute inspiratory lung volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi) | Drug | A decrease in the pain severity (VAS);opioid-sparing effect |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual-analog scale | dynamics of points 100 mm visual-analog scale | hospitalisation period, an average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the minute inspiratory lung volume using a spirometer | Comparison of minute inspiratory lung volume befor/after research using a spirometer | hospitalisation period, an average of 24 hours |
| opioid-sparing effect |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander A. Eremenko, prof | Head of the Intensive Care Unit | Study Director |
| Lyubov S. Sorokina | anesthesiologist-resuscitator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky Research National Centre of Surgery | Moscow | Russia |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D004008 | Diclofenac |
| D000700 | Analgesics |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| Analgesics | Drug | A decrease in the pain severity (VAS) |
|
|
Comparison of the number of opioid analgesics
| hospitalisation period, an average of 24 hours |
| adverse events | registration of adverse events | hospitalisation period, an average of 1 week |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |