Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery

Conditions
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Dexmedetomidine in Subarachnoidal Anesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine and bupivacaine
* Drug: Fentanyl and bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II lower abdominal surgery Exclusion Criteria: Consumption antagonists adrenergic or channel blockers Ca ++ 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge | Drug: Dexmedetomidine and bupivacaine<br>* 10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal<br>|
| Active Comparator: fentanyl<br>25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge | Drug: Fentanyl and bupivacaine<br>* 25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | during anesthesia and first 24 hours of postoperatory | 
| Numbers of patients with nauseas |  | during anesthesia and first 24 hours of postoperatory |