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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/329 | Registry Identifier | Erciyes University Ethic Committe |
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The purpose of this study to search efficacy of intra-articular dexmedetomidine addition to levobupivacaine for postoperative analgesia in arthroscopic knee surgery.
Patients between 18-65 years and with American Society of Anesthesiologists' (ASA) Physical Status class I-II, who were scheduled for arthroscopic knee surgery, were enrolled in a randomised comparative clinical trial. Blinding or masking began in the preoperative holding unit. Exclusion criteria were psychiatric illness, younger than 18 yo, who has analgesic treatment before the surgery and known hypersensitivity to relevant drugs. All patients received a standard anaesthetic protocol; ECG, heart rate, non-invasive blood pressure, oxygen saturation and temperature were monitored. After preoxygenation, general anaesthesia was induced with sodium pentothal 4 to 7 mg/kg, 1 mcg/kg fentanyl and neuromuscular block was achieved with rocuronium 0.5 mg/kg and trachea was intubated. Anesthesia was maintained with desflurane 6% and 50% oxygen in the medical air.
Randomised patients were achieved dexmedetomidine and levobupivacaine or levobupivacaine intra-articularly 10 minutes before medical tourniquet deaerated.
Postoperative analgesia was maintained with morphine in patient-controlled analgesia. Patients postoperative VAS values and analgesic consumptions were recorded in postoperative 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine | Active Comparator | Intraarticular 19 ml 0.5% levobupivacaine and 1 ml 0.9% sodium chloride administered. postoperative morphine administered for analgesia |
|
| Dexmedetomidine | Active Comparator | Intraarticular 19 ml 0.5% levobupivacaine and 1 ml (100 mcg/ml) dexmedetomidine administered, postoperative morphine used for analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | intraarticular |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic consumption | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours | |
| heart rate | before deaerate the medical tourniquet, after deaerate the tourniquet, postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Resul Altuntas, MD | TC Erciyes University | Principal Investigator |
| Ayse Ulgey, Ast Prof | TC Erciyes University | Study Director |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Dexmedetomidine | Drug | intraarticular 1 ml (100 mcg) |
|
|
| Morphine | Drug | intravenously, patient-controlled analgesia |
|
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| Visual Analog Scale-rest | postoperative 0, 30, 60, 90, 120 minutes in the PACU, 4, 6, 12, 24, 48 hours |
| Visual Analog Scale-movement | postoperative 0, 30, 60, 90, 120 minutes ,in the PACU, 4, 6, 12, 24, 48 hours |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |