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| Name | Class |
|---|---|
| Maria Tileli | UNKNOWN |
| Chryssoula Staikou | UNKNOWN |
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60 patients ASA I-III, undergoing orthopedic surgery will be randomly assigned into one of three groups, namely group A (n=20), where dexmedetomidine will be used for sedation (initial bolus dose followed by continuous infusion), group B (n=20) where midazolam will be used for sedation (initial bolus dose followed by continuous infusion) and group C (n=20), where remifentanil will be used for sedation (initial bolus dose followed by continuous infusion). All patients will receive spinal anesthesia. Duration of postoperative analgesia, total dose of patient controlled IV morphine, sedation scores, nausea and vomiting, time of ambulation, sleep quality and patient satisfaction will be recorded for the first postoperative day. Additionally chronic pain on the site of surgery will be recorded in 3 and 6 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Dexmedetomidine sedation |
|
| Group B | Active Comparator | Midazolam sedation |
|
| Group C | Active Comparator | Remifentanil sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia duration | Time of first demand for analgesia (PCA first bolus dose) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain: Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever) | 24 hours |
| Morphine consumption | Doses requested, morphine consumption in mg |
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Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for orthopedic surgery
Exclusion Criteria:
Patient denial, contraindication of spinal anesthesia or any of the agents used in the protocol, BMI above 30, Serious psychiatric, mental and cognitive disorders, Language barrier, illicit substances abuse,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandros Makris, MD, MSc, PhD | Contact | +306947076446 | makrisalexandros@hotmail.com | |
| Maria Tileli, MD | Contact | +306955258090 | mtileli@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepieion Hospital of Voula | Recruiting | Athens | 16673 | Greece |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005531 | Foot Deformities, Acquired |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Midazolam | Drug | Sedation using midazolam (initial bolus dose followed by continuous infusion) |
|
| Remifentanil | Drug | Sedation using remifentanil (initial bolus dose followed by continuous infusion) |
|
| 24 hours |
| Rescue analgesia | Paracetamol in mg consumed | 24 hours |
| Sedation | Ramsay Sedation Scale (numeric score from 1 to 6, based on responsiveness of the patient) | 24 hours |
| Complications | 24 hours |
| Delirium occurence | Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium. | 24 hours |
| Chronic pain: Graded Chronic Pain Scale (GCPS) | Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting | 6 months |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |