Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
NCT ID: NCT02582372
Last Updated: 2015-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2014-03-31
2015-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dexmedetomidine
25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge
Dexmedetomidine and bupivacaine
10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal
fentanyl
25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge
Fentanyl and bupivacaine
25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal
Interventions
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Dexmedetomidine and bupivacaine
10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal
Fentanyl and bupivacaine
25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal
Eligibility Criteria
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Inclusion Criteria
* lower abdominal surgery
Exclusion Criteria
* Patients with arrhythmias or heart block
* Allergic to any drugs under study
* Obese
* Physical or mental incapacity to understand and use the pain scale
* Contraindication for anesthesia conductive
* Realization difficulty or complication during anesthesia and / or surgery
18 Years
65 Years
ALL
No
Sponsors
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Hospital Central Dr. Luis Ortega
OTHER
Responsible Party
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Beatriz Arismendi Gómez
Clinical Professor Beatriz Arismendi Gomez
Other Identifiers
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HCLuisOrtega
Identifier Type: -
Identifier Source: org_study_id
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