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Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.
OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.
METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Experimental | 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge |
|
| fentanyl | Active Comparator | 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine and bupivacaine | Drug | 10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of baseline blood pressure | during anesthesia and 1 hour of postoperatory | |
| Changes of baseline cardiac rate | during anesthesia and 1 hour of postoperatory | |
| Changes of baseline oxygen saturation | during anesthesia and 1 hour of postoperatory | |
| Postoperatory pain visual analogue scale | during first 24 hours of postoperatory | |
| Changes of motor block using Bromage scale | during anesthesia and 1 hour of postoperatory |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of patients with hypotension using non invasive blood presure monitor | we report hypotension below 20% of basal values | during anesthesia and first 24 hours of postoperatory |
| Numbers of patients with excessive sedation using Ramsay scale |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of patients with signs of peripheral neurological toxicity using questionnaire | phone contact | during first seven days of postoperatory time |
Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 20, 2016 | |
| Reset | Apr 18, 2016 | |
| Release | Feb 25, 2018 | |
| Reset | Mar 21, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 20, 2016 | Apr 18, 2016 | |||
| Feb 25, 2018 |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl and bupivacaine | Drug | 25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal |
|
| during anesthesia and first 24 hours of postoperatory |
| Numbers of patients with nauseas | during anesthesia and first 24 hours of postoperatory |
| Mar 21, 2018 |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |